INTRAVENOUS ADMINISTRATION OF SUPRAPHYSIOLOGIC PLATELET RICH PLASMA FOR NEUROLOGICAL DISORDERS

Abstract

This invention relates in general to the field of cell-therapy treatments and more particularly, but not by way of limitation, to systems and methods for administering personalized cell-therapy treatments intravenously. In various embodiments, the system may calculate an aspiration volume needed for centrifugation to achieve a concentrated target threshold dose of 2×10.sup.6 platelets/μL for a particular cell therapy using various factors such as, for example, information about a patient and the efficiency of the concentration process.

Claims

1. A method of achieving therapeutic benefits for a patient presenting with a neurological disorder falling into the category of autoimmune, auto-inflammatory, and chronic diseases comprising: identifying in a patient a neurological disorder comprising fibromyalgia or chronic fatigue syndrome whose underlying pathophysiology is directly linked to altered gut bacteria; intravenously injecting about 7 mL of an autologous platelet-rich plasma composition having a concentration of at least about 2×10.sup.6 platelets/μL directly into a bloodstream of the patient to cause systemic release of platelet growth factors and peptides neo-vascularization in the patient in order to promote systemic circulatory repair and achieve both bacteriocidal and blood vessel formation one or more therapeutic benefits in the patient related to symptoms associated with the neurological disorder; wherein the platelet-rich plasma composition is injected into a vein of the patient at a rate of about 1 mL/second; and wherein an activator of the platelets is not added to the platelet-rich plasma composition.

2. The method of claim 1, wherein the concentration of the platelet-rich plasma composition is about 3×10.sup.6 platelets/μL.

3. The method of claim 1, wherein a dilutant is not added to the platelet-rich plasma composition.

4. The method of claim 1, wherein an anticoagulant is not added to the platelet-rich plasma composition.

5. The method of claim 1, further comprising preparing the platelet-rich plasma composition from whole blood of the patient.

6. The method of claim 5, wherein preparing the platelet-rich plasma composition from the whole blood comprises the steps of: obtaining a plasma fraction from the whole blood; isolating platelets from the plasma fraction; and resuspending the platelets in a reduced amount of plasma.

7. The method of claim 1, further comprising testing the concentration of the platelet-rich plasma composition prior to injection.

8. A method for achieving therapeutic benefits for patients presenting with a neurological disorder falling into the category of autoimmune, auto-inflammatory, and chronic diseases comprising: identifying in a patient a neurological disorder whose underlying pathophysiology is directly linked to gut dysbiosis comprising fibromyalgia or chronic fatigue syndrome; determining a baseline platelet concentration of a blood sample of the patient; determining a volume of blood to aspirate from the patient for a platelet-rich plasma treatment based at least in part on (a) a concentration target of 2×10.sup.6 platelets/μL, (b) the baseline platelet concentration, and (c) a treatment volume target of 7 mL of final concentrate; aspirating the volume of blood from the patient; concentrating the aspirated blood to obtain a treatment volume of at least about 7 mL of the final concentrate having a concentration of at least about 2×10.sup.6 platelets/μL; and injecting the final concentrate directly into a bloodstream of the patient intravenously at a rate of about 1 mL/second to cause systemic release of platelet growth factors and peptides neo-vascularization in the patient to promote systemic circulatory repair thereby achieving both bacteriocidal and blood vessel formation one or more therapeutic benefits in the patient related to at least one symptom of the neurological disorder.

9. The method of claim 8, wherein the concentration of the final concentrate is about 3×10.sup.6 platelets/μL.

10. The method of claim 8, wherein a dilutant is not added to the final concentrate.

11. The method of claim 8, wherein a saline dilutant is not added to the final concentrate.

12. The method of claim 8, wherein an anticoagulant is not added to the final concentrate.

13. The method of claim 8, wherein concentrating the aspirated blood comprises the steps of: obtaining a plasma fraction from the aspirated blood; isolating platelets from the plasma fraction; resuspending the platelets in a reduced amount of plasma; and wherein an activator of the platelets is not added to the final concentrate.

14. The method of claim 8, further comprising testing the concentration of the final concentrate prior to injection.

15. A method for administering a medical treatment to achieve therapeutic benefits for a patient presenting with a neurological disorder falling into the category of autoimmune, auto-inflammatory, and chronic diseases, the method comprising: identifying in a patient a neurological disorder whose underlying pathophysiology is directly linked to altered gut bacteria comprising fibromyalgia or chronic fatigue syndrome; determining a baseline platelet concentration of a blood sample of the patient; receiving an indication of a treatment volume of concentrate to be used in a cell-therapy treatment; calculating an aspiration volume of blood to be aspirated for the cell-therapy treatment to achieve a platelet concentration target range of 2×10.sup.6 platelets/μL, based at least in part on the baseline platelet concentration for the patient and the indicated treatment volume of platelet-rich plasma concentrate; aspirating the volume of blood from the patient; concentrating the aspirated blood to obtain a treatment volume of at least about 7 mL of the platelet-rich plasma concentrate having a concentration of at least about 2×10.sup.6 platelets/μL; and injecting the platelet-rich plasma concentrate directly into a bloodstream of the patient intravenously at a rate of about 1 mL/second to cause systemic release of platelet growth factors and peptides neo-vascularization in the patient to promote systemic circulatory repair thereby achieving both angiogenesis and bacteriocidal one or more therapeutic benefits in the patient related to at least one symptom of the neurological disorder.

16. The method of claim 15, wherein the concentration of the platelet-rich plasma concentrate is about 3×10.sup.6 platelets/μL.

17. The method of claim 15, wherein concentrating the aspirated blood comprises the steps of: obtaining a plasma fraction from the aspirated blood; isolating platelets from the plasma fraction; resuspending the platelets in a reduced amount of plasma; and wherein an activator of the platelets is not added to the platelet-rich plasma concentrate.

18. The method of claim 15, wherein a dilutant is not added to the platelet-rich plasma concentrate.

19. The method of claim 15, wherein an anticoagulant is not added to the platelet-rich plasma concentrate.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] A more complete understanding of the method and apparatus of the present invention may be obtained by reference to the following Detailed Description when taken in conjunction with the accompanying Drawings wherein:

[0032] FIG. 1 is a flowchart of a method according to an embodiment; and

[0033] FIG. 2 is a flowchart of a method according to an embodiment.

DETAILED DESCRIPTION

[0034] The present invention is directed towards systems and methods for increasing successful outcomes in cell therapy treatments. This treatment protocol may include the use of Applicant's Harbour Cell Software™ or other device to calculate exact aspiration blood volumes in order to concentrate a consistent PRP minimum dose on the order of 2.0×10.sup.6 platelets/μL for neurological disorders. Furthermore, the PRP is administered intravenously to promote circulatory repair.

[0035] One novelty of this treatment protocol includes delivering a consistent PRP dosage to all patients. The Harbour Cell Software™ may be used to determine the exact blood aspiration volume in order to achieve consistency of PRP dosing. First, a baseline platelet count was taken from each respective patient. Next, the baseline platelet count, the centrifuge recapture efficiency, injection volume, and target dose of on the order of 2.0×10.sup.6 platelets/μL were all used to calculate and display exact aspiration volumes for each patient. The aspiration volumes were highly variable for each patient, but a minimum of 2.0×10.sup.6 platelets/μL was achieved for this embodiment. In other embodiments, the concentration may be higher or lower than 2.0×10.sup.6 platelets/μL may be utilized depending on the treatment parameters. The 2.0×10.sup.6 platelets/μL dose was found to be sufficient to accomplish both bacteriocidal and blood vessel formation, which are needed for autoimmune/inflammatory neuro-related diseases.

[0036] Another novelty of this treatment protocol was the intravenous administration of the PRP. PRP is widely known and administered via a local injection to an injured site. Local administration has the drawbacks of prematurely releasing platelet growth factors and peptides, whereas the benefit of the IV administration is the systemic release during circulatory repair. During one study performed by Applicant, nine of the eleven patients received IV administration of surpraphysiologic PRP. All nine of these patients reported improvements to neurocognition, language, memory, eyesight, handwriting, focus, systemic pain relief, inflammation reduction, detoxification, and academic grade improvements. The two patients who received localized injections only reported pain relief at their injured sites. These two patients did not report any other improvements like those reported from the patients receiving the IV treatment.

[0037] Various embodiments are directed towards a cell therapy treatment protocol for neurological disorders. More specifically, a treatment protocol administering, on the order of, at least 2.0×10.sup.6 platelets/μL intravenously. In various embodiments, the treatment protocol calls for consistency of platelet dose administrations, which may be achieved by following the systems and methods of, for example, applicant's Harbour Cell Software™ to calculate exact blood aspiration volumes to achieve consistent doses.

[0038] Currently, point-of-care cell therapy lacks sufficient standardization. In various embodiments, the systems and methods may utilize the Harbour Cell Software™ for making the latest treatment protocols available to doctors, nurses, and other technicians at the point-of-care. When conducting a cell therapy treatment study in a controlled setting, several safety measures may be in place to ensure accuracy that may not be in place in a real-world setting. In both the research and real-world settings, cell therapy treatments generally include a physician aspirating a determined large volume of autologous fluid from a subject, concentrating this fluid via centrifugation to obtain a final small volume of concentrate, and then injecting this small volume concentrate to a target site. In this treatment protocol embodiment, the final small volume of concentrate is delivered intravenously for circulatory repair.

[0039] Clinical outcomes are more likely to succeed when a target concentration is achieved prior to centrifugation. Furthermore, the advancement of cell therapy regenerative medicine can occur when methods and devices insuring quality control and dose consistency are understood and administered. In order for one to be sure enough total cells are present to centrifuge, despite all of the other variables, one must aspirate the appropriate volume from the patient to reach a desired target platelets/μL in the final volume of concentrate. Physicians often determine their aspirating volume by the centrifuge kit volume limitations, habitually aspirate the same volumes for each patient, or stop aspirating when they feel they have enough.

[0040] In various embodiments, systems and methods utilizing the Harbour Cell Software™ ensure the appropriate amount of target platelets/μL has been achieved in the final small volume of concentrate. In the present embodiment, neurological improvements were achieved by delivering consistent target platelets/μL intravenously.

[0041] The underlying manifestations that affect neurodegenerative, sensory, cognitive, rehabilitation, and endocrine disorders are multifactorial and complex. However, an appropriately dosed PRP therapy may offer new hope in addressing its causation. Epitheilial, endotheilial, and PRP-derived growth factors could address intestinal and vascular permeability causations, as well as, revascularization. Phagocytotic PRP peptides and macrophage reprogramming could not only restore gut dysbiosis, but remove free roaming neurotoxic bacteria, pathogens, and viruses. Furthermore, phagocytosis would address cell-invading small-colony variant bacteria capable of cell mimicry and disruption of cell mitochondria. Remyelination of neuronal axons, via brain derived neurotrophic factor, could restore connectivity and axonal protection from free roaming bacteria/pathogens and viruses. Lastly, PRP/macrophage induced inflammation would signal an orchestrated tissue repair remodeling cascade (tissue genesis) via paracrine signaling and cell proliferation/differentiation choreographed via platelets and growth factors. Various embodiments of treatment methods may include using Applicant's Harbour Cell Software™ to ensure consistent and accurate results, discovery and refine new treatment methods, and/or supraphysiologic dose administration intravenously of PRP.

[0042] To date, nothing within the clinical literature can be found investigating, demonstrating, or reporting the clinical findings described herein and, ultimately, the discovery of a treatment method for intravenous administration of PRP for neurological disorders. Furthermore, there are no reports characterizing consistent platelet dosing of PRP-IV treatments for neurological disorders.

[0043] In various embodiments, the treatment method may include a testing protocol, AI dose learning, and/or an intravenous administration protocol of the PRP. In a first step, various patient demographics may be inputted into the software for learning. Demographics can include, but not limited to, disease state information, health information, objective patient characteristics and lifestyle information. For example, the medications a patient is taken, the patient's history of viral infections, and/or consumption of alcohol, all of which may affect platelet counts, may be inputted. Demographic information may also include genomic and genetic specifics of individual patients. This information is compared against the learning database to determine the degree of impact each demographic variable potentially has on outcome success. Over time, the learning metrics understand the degree of each independent variable impacting outcome success which is then correlated back to dosage.

[0044] In a second step, a patients baseline platelet count is established, such as via finger stick (capillary sampling). Following the inputting of demographic information, a capillary sampling of blood may be executed. The blood sample could be sampled and counted different ways known to those skilled in the art. In some embodiments, blood sampling testing kits may be used that contain specific capillary tubes and testing slides to increase accuracy.

[0045] In a third step, the exact aspiration volume for centrifugation is calculated. Once the demographic information and baseline platelet count have been inputted into the software, a blood aspiration calculation may be determined and displayed. The learning software may accounts for demographic variability, baseline cell counts, and/or previous recorded outcomes to determine an overall dose-to-outcome relationship. For example, the software may have learned that a minimum dose/mL is needed for success of a treatment for a certain disease. For a patient presenting with that disease and having several demographic variables that impact baseline cell counts, the software may be able to adjust accordingly. Baseline cell count is one of several variables that impact dosing inaccuracy. Additionally, other variable can impact the calculations. For example, individual operators (human error) have different variabilities of performance that are often unavoidable. The artificial intelligence software may learn individual operator performance deviations and may include that in the various metrics factored into patient aspiration calculations. Based on these collective learning metrics and algorithms, the software may then calculate the patient-specific blood aspiration volume needed to produce the minimum consistent therapeutic dose/mL for the disease treatment.

[0046] At a fourth step, target dose is tested post-centrifugation for re-aspiration or dilution adjustments. Following centrifugation, the testing protocol may call for confirmation of the target dose. A sample of the final concentrate is collected and a measurement is initiated. Once the final measurement is inputted into the software, dilution calculations or re-aspiration calculations are performed. By way of example, in real-world patient encounters, Applicant's software has achieved better than 95% accuracy in calculating a blood aspiration that will produce a desired target dose.

[0047] At a fifth step, re-aspiration for centrifugation or dilution adjustments to reach desired target dose are performed. It is often easier to dilute than to re-aspirate, re-centrifuge, homogenize to final concentrates, re-test and verify. Therefore, the learning metrics can be defaulted to err on the side of over aspiration to avoid those time-consuming processes. At a sixth step, the treatment therapy is administered. At a seventh step, patient follow up and documentation of validated outcomes are measured. The determination of a dose-to-outcome response is dependent on the outcome success of the treatment. Outcome success is collected by the scientific and medical community via validated measurements scales depending on the disease and condition. For example, the pain VAS measurement scale is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations for various treatments and outcome measurements. The change in a patient's pain measurement is an example of a successful treatment outcome metric that may be incorporated into the learning algorithms intended to learn a dose-to-outcome response.

[0048] Using the learning software, Applicant has discovered new dosages for treating AAC diseases. Applicant conducted a series of validation studies to satisfy FDA requirements. An Institutional Review Board (IRB)-approved validation study was executed to originally only include 10 patients. The first patient, and each subsequent patient, consented and elected to have the PRP intravenously administered due to various ailments all related to AAC diseases. After demographic data was collected, a licensed, board-certified physician auto-transfused the PRP using guidelines set forth by the American Society of Hematology (ASH). The first few patients reported remarkable and similar improvements related to neurocognition, sensory, communication and other metabolic changes. Unexpectedly, due to these initial results, patient word of mouth turned the small validation study into 100 patients being treated. All patients fell into the category of having an AAC disease. All patients had exhausted conservative treatments and, seeking an alternative treatment, consented to IV PRP administration. Thus, Applicant initiated an outcome survey questionnaire for the purposes of learning a successful dose-to-outcome response and neurological exams for learning the dose for individual improvements.

[0049] In one embodiment, a quality of life questionnaire was given and neurological assessment measurements were taken. These validated measurement scales were used to determine positive response and metrics from these responses were correlated with PRP dosage. In certain variations, several validated measurement scales could be used in a similar manner to correlate positive outcomes success to minimum dose. Other quality of life surveys or neurological measurement exams can be used and the software can accommodate the inputting of various scales for learning.

[0050] In another embodiment, the learning algorithm correlates the various positive metrics of the outcome scales to the various PRP doses delivered. The software may be designed to determine a dose-to-outcome response with greater than 90% confidence. From the 100 patients treated, the software determined 2.0×10.sup.6 platelets/μL was the minimum therapeutic PRP dose needed for patient positive response. In certain variations, the % confidence of learning software may comprise of a range anywhere from 1-100%.

[0051] In another embodiment, the preparation of the PRP may involve a blood phlebotomy and centrifugation. The blood phlebotomy may be executed using World Health Organization guidelines via a butterfly needle, tourniquet, stopcocks, and multiple syringes. The centrifugation preparation process may involve a two-step centrifugation process for PRP sedimentation. In order to produce a supraphysiological concentration of platelets per μL may require a two-step process. Many clinicians only execute a one-step centrifugation protocol to produce PRP, which is often not capable of producing high concentrations of platelets. There are many two-step PRP processing kits commercially available. For example, the Pure PRP system from Emcyte Corporation is a commercially available PRP kit that involves a two-step preparation process. The Pure PRP system first uses a canister for RBC and platelet supernatant sedimentation. Following the first centrifugation spin, the operator withdraws the lighter supernatant and injects this into the second and final processing canister for separation. The second centrifugation spin separates the platelet supernatant into platelet poor plasma and platelet rich plasma. Once centrifugation is finished, the operator removes a volume of platelet poor plasma and continues by homogenizing the remaining volume. The volume of platelet poor plasma can be a various percentage depending on the final volume of PRP needed for injection. The percentage can be anywhere from 1-95% of the total volume being removed. Depending on the calculated blood amount, either one or two cylindrical canisters may need to be filled with an appropriate amount of blood. If only one canister was used, a counterweight may be used to balance the first canister. In either scenario, the first centrifugation spin may be executed for two minutes at 3800 rpm to isolate red blood cells and platelet supernatant. The platelet supernatant may then be removed and placed in a third canister for isolation of platelet poor plasma and platelet rich plasma. Whether a single or double canister, the second spin may be executed for seven minutes at 3800 rpm to produce a final PRP concentrate of a minimum 2.0×10.sup.6 platelets/μL. Following centrifugation, a small aliquot of PRP may be removed to confirm a 2.0×10.sup.6 platelets/μL dose. In trial cases, the minimum 2.0×10.sup.6 platelets/μL was achieved and an injection volume of 7 mL was infused to patients intravenously at 1 mL/second. In other cases, the concentration was increased to 2.5×10.sup.6 platelets/μL and in other cases, to, on the order of, 3.0×10.sup.6 platelets/μL or higher. In some embodiments, the dose was administered at 0.5 mL/second or lower, while in others it was administered at 1.5 mL/second, 2.0 mL/second or higher. In some embodiments, the injection volume was between about 6 mL to 8 mL, while in others it was reduced to below 6 mL, while in others it was increased to above 8 mL.

[0052] In some variations, the PRP preparation protocol could be a variation of centrifugation times and forces for both the RBC sedimentation and PRP sedimentation. Times can range anywhere from 1-20 minutes or more depending on the step of the process. Forces can range anywhere from using gravity to a centrifugation force up to 100,000 rpm. The time needed for sedimentation in the two steps would be proportional to the forces being used.

[0053] In some variations, the PRP processing components can be a variety of shapes and sizes. PRP processing components can also be a commercially available PRP kit or a combination of assembled components. For example, a minimum 2.0×10.sup.6 platelets/μL dose may be achieved with laboratory conical tubes. The conical tubes may require a larger calculated amount of blood draw, however, a two-step centrifugation process may still apply, as well as, determined time and centrifugation force. In either scenario, the performance of the commercial processing kit or manual processing method is one of the variables of blood aspiration calculations. The learning software algorithms learn the standard deviation of performance for the method being used to help calculate consistent PRP doses.

[0054] In some variations, the PRP preparation process involves a human operator whereby introducing human error. Any additional errors affect blood aspiration calculations which ultimately impact consistency of the dose. For example, a first operator could add an additional 10% of error compared to a second, more skilled, operator. The learning software metrics learn the proficiency of different operators as another variable influencing the consistency of dosing.

[0055] In another embodiment, a small aliquot sample is used for measurement to determine the minimum 2.0×10.sup.6 platelets/μL has been achieved. Following centrifugation and homogenization of final concentrate sample, a transfer cup may be used to procure, for example, a 5 μL sample for analysis and measurement. The volume of measurement could be various volumes depending on the measurement instrument being used.

[0056] In another embodiment, a small aliquot sample is used for measurement to determine the patient's baseline platelet count. The baseline platelet count is another variable factored into the intelligent aspiration calculations. For example, a 20 μL capillary sample may be taken and used for measurement. The volume of measurement could be various volumes depending on the measurement instrument being used.

[0057] In some variations, the PRP compositions of each individual may comprise of varying concentrations of various types of white blood cells, lymphocytes, monocytes, eosinophils above their respective baseline counts. These concentrations over baseline are typically reported as “times baseline.” For example, the concentrations may vary between 1×-10× over their respective baseline. The concentrations of lymphocytes and monocytes may be between about 1.1 and about 2 times baseline, about 2 and about 4 times baseline, about 4 and about 6 times baseline, about 6 and about 8 times baseline, or higher. The concentrations of eosinophils in the PRP composition may be about 1.5 times baseline. In some variations, the lymphocyte concentration is between about 5,000 and about 20,000 per μL and the monocyte concentration is between about 1,000 and about 5,000 per μL. The eosinophil may be between about 200 and about 1,000 per μL.

[0058] In certain variations, the PRP composition may contain a specific concentration of neutrophils. The concentration may vary between less than the baseline concentration of neutrophils to eight times the baseline concentration of neutrophils. In some variations, the neutrophil concentration may be between 0 and about 0.1 times baseline, about 0.1 and about 0.5 times baseline, about 0.5 and 1.0 times baseline, about 1.0 and about 2 times baseline, about 2 and about 4 times baseline, about 4 and about 6 times baseline, about 6 and about 8 times baseline, or higher. The neutrophil concentration may additionally or alternatively be specified relative to the concentration of the lymphocytes and/or the monocytes. In preferred embodiments, the neutrophil concentration is less than the concentration in whole blood. In other embodiments, the neutrophil concentration is 0.1 to 0.9 the concentration found in whole blood, yet more preferably less than 0.1 the concentration found in whole blood. In other embodiments, the neutrophils are eliminated or non-detectable in the PRP composition.

[0059] The results from this study proves the novelty of the intelligence software and ultimately the novelty of the treatment methods described herein. Dosing inaccuracy and lack of standardization is a widely known problem within the scientific literature, especially PRP. Because there has been a lack of tools to help prepare consistent dosing, treatment protocol discovery has stalled in the regenerative medicine field. Reducing Applicant's Harbour Cell Software to practice led to unexpected clinical findings and the discovery of novel neurological cell therapy treatment protocols, including supraphysiologic dose administration intravenously of PRP. In this 100-patient study, 100 patients presented with an AAC disease and, after receiving the novel treatment protocols described herein, of the 100 patients, 92% reported an improvement in quality of life surveys. In 49% of them, this item was evident with statistical significance (p<0.005). In those patients with neurological tare an improvement in the cognitive sphere was observed in 70% of them (greater capacity for concentration, language or ability to perform more complete tasks) with statistical significance (p<0.002).

[0060] Referring now to FIG. 1, a flowchart is provided of an embodiment of a method 100 of providing a treatment protocol using a user device. At step 102, a user is prompted to select whether the use will be for research purposes or for non-research purposes. In various embodiments, at step 104, patient information and/or de-identified demographics of the intended subject could be inputted or selected from a drop down menu, such as, for example, whether the subject is human or animal, the sex of the subject, age, name, initials, or other indicia, treating physician, facility, location, and other relevant information. Such information may be useful for tracking, data and research collection purposes. These selections may be inputted and displayed via the user device.

[0061] At step 106, the user begins the calculation workflow. At step 108, the user device receives input from the physician regarding specialty. If being used for non-research purposes, then the user device may be programmed to prompt specialty selections that are within the published literature showing cell therapy human outcomes within the specified specialty. If the specialty is not reported in published literature or not published with human outcomes, then, at step 108, the physician may be prompted to add the specialty before proceeding through the workflow prompt. When a new specialty is added, the physician may be notified by the user device that it will no longer be accessing the cloud based and/or embedded published outcomes. The device may still proceed through the workflow prompts and calculate the needed autologous volume, however, the physician may be prompted that the volume calculated is intended for an experimental specialty use not reported in the published literature.

[0062] In the current treatment protocol embodiments, the physician specialty would fall under those pertaining or who treat neurological disorders (i.e., neurologist, neurosurgeon, rheumatologist, etc.). The Harbour Cell Software™ may be utilized for research purposes, and thus falling into the category of not reported in published literature.

[0063] At step 110, the device receives input from the physician regarding an intended treatment. If being used for non-research purposes, then the device may prompt treatment selections based at least in part on the specialty selection that are within published literature showing cell therapy human outcomes. If the intended treatment is not reported in published literature or not published with human outcomes, then the physician will be prompted to add the treatment before proceeding through the workflow prompt. If a treatment is added, then the physician may be notified by the machine that it will no longer be accessing the cloud based and/or embedded published outcomes. The device may still proceed through the workflow prompts and calculate the needed autologous volume, however, the physician may be prompted that the volume calculated is intended for an experimental treatment use not reported in the published literature. The physician may need to acknowledge this before proceeding to the next workflow prompt. If the device is being used for research purposes, then the physician may input the designated specialty.

[0064] In the current treatment protocol embodiment, IV dose administered PRP treatment is not reported in published literature and therefore must be inputted into the software before proceeding with the workflow prompts.

[0065] At step 112, the device receives input from the physician regarding an intended autologous source and strength number. The Harbour Cell Software™ incorporates these attributes as part of the workflow so physicians can be informed of the most current published methods during the course of treatment workflow. In the current embodiment, this treatment protocol discovery falls into the experimental treatment workflow prompts that are not reported in literature. The autologous source entered is autologous blood-PRP.

[0066] At step 114, the device receives input from the physician regarding concentration volume needed. If being used for non-research purposes, the device may only prompt a default numerical concentration milliliter volume, determined from the treatment selection. The defaulted volume may be based at least in part on the relevant published literature. The treatment targeted cell range per μL is displayed for the physician to view and confirm. In the current treatment protocol embodiment, a minimum of, on the order of, 2.0×10.sup.6 platelets/μL was inputted as the target as there is no established target range of neurological disorders. Considering many neurological disorders require phagocytosis of various pathogens and bacteria, as well as, re-establishing blood vessel formation (neo-vascularization), the current target dose was chosen to encompass both established angiogenic and bacteriocidal in-vitro dose capabilities. The physician may have the option to increase or decrease the concentration volume by selecting plus (+) and minus (—) signs. The value for the starting volume needed to achieve the concentration volume needed for treatment is calculated based at least in part on the different inputs received during the workflow. Any number of calculations can be used to determine starting volume needed to maintain target platelets/μL necessary for the intended treatment. Changing various inputted values will affect the resulting calculations.

[0067] At step 116, the device receives input from the physician regarding the concentration machine being used. The performance criteria is another example of a value that may influence the starting volume calculation. This is due to the known studied performance variabilities of commercial cell concentration devices. The physician may have options to add a machine. When adding a machine, a weighted performance average may be calculated to determine the starting volume calculation. In this scenario, the device may notify the physician that a weighted average is being used to determine the final calculations and not a known performance for the added machine. In the current treatment protocol embodiment, an established commercial centrifuge was utilized with similar performance characteristics and weighted average calculations to other known commercial centrifuges. These machine performance criteria were utilized to determine the final aspiration calculations to achieve consistent PRP concentrate yields of 2.0×10.sup.6 platelets/μL for this particular concentration device.

[0068] At step 118, the user device receives baseline cell numbers that will be used for calculations. The baseline cell number can be taken by any commercially available cell counter, platelet counter, hemocytometer, or like device. The user device may receive the baseline numbers via manual input or via wired or wireless connection to the counter and/or other backend system to determine which calculation should be performed: for platelets, RBCs, HSCs, WBCs, exosomes, adipose pre-cursor cells, or MSCs. The user device can also be connected, either wired or wirelessly, to capable cell counting devices in order to transfer baseline data instead of manual input. These selections are displayed and received via the user device. Information provided by the system based at least in part on user inputs may assist the user in determining the source material to be used in the treatment. Because the baseline may vary depending on the source material, in various embodiments, although not required, it may be preferable for a user to input other information (e.g., specialty, treatment, and/or autologous source) before determining and/or inputting the baseline cell number. In the current treatment embodiment shown, the baseline platelet number is inputted after various other information has been entered.

[0069] At step 120, the device displays the starting volume amount of autologous source volume needed to be aspirated from the subject. This final calculation is determined based at least in part on the previous inputs from the clinician. This starting volume is the final calculated volume needed from the individual subject, to be concentrated, in order to concentrate a final treatment volume containing a minimum of 2.0×10.sup.6 platelets/μL range.

[0070] In some embodiments, the device may also determine dilution and/or hyperconcentration calculations. Dilution and/or hyperconcentraton calculations may be an important value to know following machine concentration. By way of example, in various embodiments of the system, the starting volume was calculated to ensure an appropriate target platelets/μL treatment yield is achieved. Following machine concentration, a physician can test a small aliquot sample of the concentrate. If the platelets/μL volume exceeds the intended target, the excess plasma or other fraction of the separation can be added to dilute the concentrate in order to achieve the intended target platelets/μL. The treatment system may calculate exactly how much dilution should be added. The opposite would occur if too little target platelets/μL were achieved. If the target platelets/μL is less than the intended target treatment need, then hyperconcentration would need to occur. In this case, a cell analysis of the concentrate would be used by the system to make the hyperconcentration calculations. The system would calculate the amount of excess plasma or separated fraction to be removed from the concentrate. This would yield a total volume less than the desired treatment volume, but would be at the desired treatment target platelets/μL. Any number of weighted algorithms and calculations could be used to determine the final volume needed or other values within the equation. In the current treatment protocol embodiment, a minimum of 2.0×10.sup.6 platelets/μL was achieved before administering.

[0071] Referring now to FIG. 2, a PRP treatment method 200 is provided. At step 202 the method begins. In one embodiment of the treatment protocol, whole blood is aspirated from a patient at step 204. Next, at step 206, the whole blood is concentrated by obtaining a plasma fraction of the whole blood and isolating the platelets therefrom at step 208. Then the platelets are re-suspended at step 210 and the concentration of the final concentrate is tested at step 212. Finally, the PRP concentrate is administered via intravenous injection under time-controlled administration (approximately 1 mL per second) at step 214. Prior to IV injection, careful filtering of any impurities was undertaken to the PRP concentrate. Dose specific PRP-IV administration is indeed novel due to PRP being historically delivered only at the injury site. The novel aspect of the PRP-IV administration is the theoretical homing phenomenon whereby cells migrate to the organ of their origin or to repair. With neurodegenerative diseases, there are many underlying repair needs. The body releases platelets during times of repair. The current IV circulatory repair approach allowed high concentrations of platelets to home to various sites of repair before orchestrating a paracrine repair process and release of platelet growth factors. The current treatment protocol approach proved this as evident by patients reporting more than one improvement in neurological functions. In contrast to historic PRP site injections, growth factors are released immediately and focused to a specific injury. Again, this proved evident as the two patients who received site injections did not report any other benefits than the injury site pain relief. Therefore, PRP-IV administration promoting systemic circulatory repair proved beneficial.

[0072] In another aspect, the proposed treatment protocol adhered to a specific minimum dose concentration for each patient. Currently, there are no devices for PRP cell therapy that provide a method of quality control and standardization like the Harbour Cell Software™. In the absence of such device and standardization, physicians are either delivering suboptimal treatments or potentially inhibitory treatments. The lack of standardization and quality control inhibits the advancement of cell therapy knowledge. For example, a concentration of 3 billion platelets per mL may be inhibitory to tenocyte and neo-vascularization behavior. Knowing the optimal concentration range is not helpful unless the amount of injected PRP volume, the concentration machine used, the starting volumes used to concentrate, and/or the absolute value of platelets is also known. Aspirating the same amount of blood in each patient is not a scientifically sound way to reach the optimal concentration range. For example, if one patient has a baseline of 150,000 platelets/μL and another has a baseline of 350,000 platelets/μL, then aspirating the same volume creates a significant variable. The current treatment protocol embodiment uses the Harbour Cell Software™ to eliminate the inherent variabilities, deliver consistent doses, and prohibit inhibitory concentrations.

[0073] Although various embodiments of the method and apparatus of the present invention have been illustrated in the accompanying Drawings and described in the foregoing Detailed Description, it will be understood that the invention is not limited to the embodiments disclosed, but is capable of numerous rearrangements, modifications, and substitutions without departing from the spirit and scope of the invention.