A Phase 4 interventional study of Pure PRP II and PureBMC in Knee Osteoarthritis, sponsored by Andrews Research & Education Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Andrews Research & Education Foundation · Phase 4, Interventional, and Treatment
This study is intended to compare whether bone marrow aspirate concentrate or platelet rich plasma injections is more effective in treating knee osteoarthritis.
While PRP shows promise in helping restore function to these patients, there are still concerns with PRP's long term outcomes. Another option that has become more popular for physicians treating this debilitation condition is bone marrow aspirate concentrate (BMA), which use's undifferentiated cells found in the bone marrow to promote healing and tissue regeneration. These cells have the ability to replicate into a multiple different tissue types. With BMA, the marrow is concentrated provide better healing of the damaged tissue and aid in growth and repair. The full benefits of BMA are still unknown, but studies have shown the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage and bone grafts.
Autologous BMA has shown promising clinical potential as a therapeutic agent in regenerative medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical efficacy platelet rich plasma has been documented to alleviate symptoms related to knee osteoarthritis. However, randomized, prospective comparison of the two techniques has not been reported in the literature and long term follow-up for both treatments is limited, and especially limited in the use of BMA for osteoarthritis treatment.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 90 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Andrews Research & Education Foundation is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood will be drawn from the patient using the Pure PRP II system into a syringe with anticoagulant (sodium citrate). 1 mL of blood will be separated and sent to a lab for analysis. Remaining blood will be separated into a single concentrating device and centrifuged to separate red blood cells from plasma and platelets. The plasma and platelets will be separated off with a syringe and re-centrifuged to separate the platelets from the plasma. 1 mL will be separated and sent to a lab for analysis leaving 6 mL for injection. Both the 1 mL of blood and the 1 mL of PRP will be sent to an independent lab to undergo analysis for CBC, TNC, human CD34+ hematopoietic stem/progenitor cell assay and CFU-F. Physician will then inject the PRP into the affected knee joint.
Combination Product: Pure PRP II
Bone marrow will be harvested from the posterior iliac crest using the PureBMC system. 50 mL of bone marrow will be drawn into one syringe containing 10 mL of sodium citrate. Marrow will be filtered and centrifuged for separation of the bone marrow concentrate. Plasma and cell concentrate will be separated off with two syringes and re-centrifuged to separate the cell concentrate from the plasma. After plasma is drawn off, BMC will be drawn into a syringe for injection into affected knee. BMC production procedure results in 7 mL of product and 1 mL will be separated and sent to a lab for analysis. Both 1 mL of BMA and 1 mL of BMC will be sent to an independent lab to undergo analysis for CBC, TNC, human CD34+ hematopoietic stem/progenitor cell assay and CFU-F.
Combination Product: PureBMC
The Pure PRP II system will be used to collect and concentrate blood into platelet rich plasma that will be injected into the knee.
Also known as: GS60-PURE-II
The PureBMC system will be used to collect and concentrate bone marrow aspirate into bone marrow concentrate that will be injected into the knee.
Also known as: BC60-PURE
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measurements
Pain score measurements utilizing patient surveys; scale 0-20 with 20 being most pain and 0 being least pain
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Subjective International Knee Documentation Committee Subjective Score (IKDC)
Pain score measurement utilizing patient surveys; scale is 0-100 with 0 being lowest level of function and 100 being the highest
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
| Milestone | Platelet Rich Plasma (PRP) | Bone Marrow Concentrate (BMC) |
|---|---|---|
| Started | 41 | 49 |
| Completed | 41 | 49 |
| Not completed | 0 | 0 |
Pain score measurements utilizing patient surveys; scale 0-20 with 20 being most pain and 0 being least pain
| score on a scale | Platelet Rich Plasma (PRP) | Bone Marrow Concentrate (BMC) |
|---|---|---|
| Baseline | 32.1 (26.4 to 37.9) | 35.3 (29.9 to 40.6) |
| 1 month | 19.5 (14.6 to 24.4) | 19.8 (15.2 to 24.3) |
| 3 Months | 18.2 (13.7 to 22.8) | 15.2 (11 to 19.4) |
| 6 Months | 16.2 (11 to 21.5) | 19.4 (14.5 to 24.3) |
| 9 Months | 18.4 (13.1 to 23.7) | 17.6 (12.7 to 22.6) |
| 12 Months | 16.8 (11.5 to 22.1) | 19.4 (14.5 to 24.3) |
Pain score measurement utilizing patient surveys; scale is 0-100 with 0 being lowest level of function and 100 being the highest
| score on a scale | Platelet Rich Plasma (PRP) | Bone Marrow Concentrate (BMC) |
|---|---|---|
| Baseline | 47.4 (42.5 to 52.3) | .909 (-6.3 to 7.0) |
| 1 Month | 58.4 (52.5 to 64.4) | 58.5 (53 to 64.1) |
| 3 Months | 61.6 (56.2 to 67.1) | 63.6 (58.6 to 68.7) |
| 6 Months | 65 (58.5 to 71.5) | 63.7 (57.6 to 69.7) |
| 9 Months | 63.1 (56.3 to 69.9) | 63.7 (57.4 to 70) |
| 12 Months | 63.7 (57.2 to 70.1) | 64.3 (58.3 to 70.3) |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Platelet Rich Plasma (PRP) | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Bone Marrow Concentrate (BMC) | 0/49 (0%) | 2/49 (4.1%) | 0/49 (0%) |
| Event | Platelet Rich Plasma (PRP) | Bone Marrow Concentrate (BMC) |
|---|---|---|
| Patient Hospitalized due to Unrelated AilmentsGeneral disorders | 0/41 | 1/49 |
| Patient Withdrawn due to Unrelated AilmentsImmune system disorders | 0/41 | 1/49 |
| Age, Continuous(years) | Platelet Rich Plasma (PRP) | Bone Marrow Concentrate (BMC) | Total |
|---|---|---|---|
| Mean | 52.2 ± 12.4 | 55.8 ± 11.3 | 54.1 ± 11.9 |
| Sex: Female, Male(Participants) | Platelet Rich Plasma (PRP) | Bone Marrow Concentrate (BMC) | Total |
|---|---|---|---|
| Female | 18 | 21 | 39 |
| Male | 23 | 28 | 51 |
| Race and Ethnicity Not Collected(Participants) | Platelet Rich Plasma (PRP) | Bone Marrow Concentrate (BMC) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Platelet Rich Plasma (PRP) | Bone Marrow Concentrate (BMC) | Total |
|---|---|---|---|
| United States | 41 | 49 | 90 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Andrews Research & Education Foundation