BMAC and LAC + LP-PRP for Osteoarthritis

(ABLE-OA Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Sowmya Viswanathan, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: University Health Network, Toronto

Must not be taking: Opioids, NSAIDs, Corticosteroids, others

Disqualifiers: Rheumatoid arthritis, Hemophilia, Leukemia, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

ABLE OA is a Health Canada authorized (phase II/III) trial \[Parent Control #: 263591\]. A multi-center, prospective, double-blinded, randomized, placebo-controlled adaptive trial to evaluate the efficacy of two minimally manipulated autologous cellular preparations i) bone marrow aspirate (BMA) injection; and, ii) combined lipoaspirate micronized (LAM) and leukocyte poor (LP) platelet-rich plasma (PRP) injections for the treatment of knee osteoarthritis (OA). BMA, LAM from lipoaspirate (LA), and LP-PRP from whole blood will be prepared using the Cervos Marrow Cellution™ Bone Marrow Aspiration System, Cervos LIPO-PRO™ Adipose Transfer System, and Cervos KEYPRP Platelet Separator System, respectively. Patient-reported outcome (PRO) measures will be collected using web- or paper-based questionnaires administered at baseline (pre-injection) as well as at 3, 6 and 12 months (post-injection). Blood, synovial fluid, and urine samples will be collected at baseline pre-injection and 6 months post-injection only.

Will I have to stop taking my current medications?

The trial requires that you stop using non-steroidal anti-inflammatory drugs (NSAIDs) at least 1 week before the procedure and avoid daily opioid use for 3 months prior. If you are on anti-platelet medications, you must be able to stop them as well.

What data supports the effectiveness of the treatment BMAC and LAC + LP-PRP for Osteoarthritis?

Research shows that patients with knee osteoarthritis who receive platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC) injections have better outcomes than those who receive hyaluronic acid. Additionally, case reports indicate that combining BMAC and PRP can improve pain and functionality in patients with knee osteoarthritis.

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Is the combination of BMAC and LAC + LP-PRP safe for treating osteoarthritis?

Research indicates that treatments using Bone Marrow Aspirate Concentrate (BMAC) and Platelet-Rich Plasma (PRP) are generally safe for knee osteoarthritis, with studies showing improved pain and functionality without significant safety concerns.

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How is the BMAC and LAC + LP-PRP treatment for osteoarthritis different from other treatments?

This treatment is unique because it combines bone marrow aspirate concentrate (BMAC), which contains stem cells that may help regenerate tissue, with lipoaspirate and leukocyte-poor platelet-rich plasma (LAC + LP-PRP), which provide growth factors to reduce inflammation and promote healing. This combination aims to improve pain and function in osteoarthritis more effectively than using these components separately.

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Eligibility Criteria

This trial is for adults at least 30 years old with chronic knee pain from osteoarthritis (grades 2 or 3), a body mass index of 30 kg/m2 or less, and who can follow the study's procedures. Excluded are those with certain cancers, recent knee surgery, infections in the knee, allergies to local anesthetics, other joint issues causing pain, major leg misalignment, inflammatory diseases like rheumatoid arthritis, blood clotting disorders, opioid use within three months prior to the study start date.

Inclusion Criteria

Body mass index ≤ 30 kg/m2

I have long-term pain in one knee.

Willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions

Exclusion Criteria

My knee is currently infected.

A history of local anesthetic allergy

My knee bends inward or outward more than 10 degrees.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular injections of either BMA or LAM + LP-PRP or placebo

Single injection

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 visits (in-person) at 3, 6, and 12 months

Data Collection

Collection of patient-reported outcomes and biological samples

6 months

2 visits (in-person) at baseline and 6 months

Participant Groups

The ABLE OA trial is testing two treatments for knee osteoarthritis: one group receives bone marrow aspirate concentrate (BMAC) injections and another gets lipoaspirate concentrate (LAC) combined with leukocyte-poor platelet-rich plasma (LP-PRP). Both groups will be compared against saline placebo injections. The effectiveness will be measured through patient questionnaires and analysis of blood, synovial fluid and urine samples before treatment and after several months.

Group I: For STUDY 2 (ARM B): Lipoaspirate Micronized + Leukocyte-Poor Platelet-Rich Plasma (LAM + LP-PRP) Experimental Treatment 1 Intervention

This group will undergo a blood collection plus lipoaspiration and receive an ultrasound guided intra-articular injection of LAM (a single dose of cellular suspension of 9 mL or less) followed by LP-PRP (a single dose of cellular suspension of 2 mL or less)

Group II: For STUDY 1 (ARM A): Bone Marrow Aspirate (BMA) Experimental Treatment 1 Intervention

This group will undergo a bone marrow aspiration and receive an ultrasound guided intra-articular injection of BMA (a single dose of cellular suspension of 9 mL or less)

Group III: For STUDY 2 (ARM D): Saline Injection Placebo Group 1 Intervention

This group will undergo a blood collection plus lipoaspiration and receive ultrasound guided intra-articular injections of saline solution (9 mL followed by 2 mL)

Group IV: For STUDY 1 (ARM C): Saline Injection Placebo Group 1 Intervention

This group will undergo a bone marrow aspiration and receive an ultrasound guided intra-articular injection of saline solution (9 mL)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Women's College Hospital Toronto, Canada

Toronto Western Hospital, University Health Network Toronto, Canada

Cleveland Clinic Canada Toronto, Canada

Who Is Running the Clinical Trial?

University Health Network, Toronto Lead Sponsor

Women's College Hospital Collaborator

Cleveland Clinic Canada Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Patients With Knee Osteoarthritis Who Receive Platelet-Rich Plasma or Bone Marrow Aspirate Concentrate Injections Have Better Outcomes Than Patients Who Receive Hyaluronic Acid: Systematic Review and Meta-analysis. [2023] To systematically review the literature to compare the efficacy and safety of platelet-rich plasma (PRP), bone marrow aspirate concentrate (BMAC), and hyaluronic acid (HA) injections for the treatment of knee osteoarthritis (OA).

2. Romania pubmed.ncbi.nlm.nih.gov

Comparing PRP and bone marrow aspirate effects on cartilage defects associated with partial meniscectomy: a confocal microscopy study on animal model. [2021] The aim of our study was to assess the therapeutic effects of platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) in an animal knee lesion complex associating a large osteochondral defect and meniscal defect resulted from partial meniscectomy, a clinical situation that occurs quite often in orthopedic practice.

3. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes After Platelet-Rich Plasma, Bone Marrow Aspirate, and Adipose-Derived Mesenchymal Stem Cell Injections for Symptomatic Knee Osteoarthritis. [2022] The objective of this study was to compare platelet-rich plasma (PRP), bone marrow aspirate concentrate (BMAC), and adipose-derived mesenchymal stem cell (MSC) injections in the treatment of osteoarthritis (OA) of the knee using functional scores.

4. England pubmed.ncbi.nlm.nih.gov

Bone marrow aspiration concentrate and platelet-rich plasma in the treatment of knee osteoarthritis: A report of three cases. [2019] This paper presents the cases of 3 females with knee osteoarthritis. All 3 received a single bone marrow aspiration concentrate (BMAC) injection followed one month later by a platelet-rich plasma (PRP) injection. Compared with the baseline values, pain and functionality scores improved in all the patients. The aim of presenting these cases is to highlight that the combined use of intra-articular BMAC and PRP treatments may have positive effects on pain, functional status and quality of life in patients with knee osteoarthritis.

5. United States pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial. [2022] Autologous platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMC) are being used clinically as therapeutic agents for the treatment of knee osteoarthritis.

6. United States pubmed.ncbi.nlm.nih.gov

In vivo comparison of the bone regeneration capability of human bone marrow concentrates vs. platelet-rich plasma. [2022] Bone marrow aspirate concentrate (BMAC) including high densities of stem cells and progenitor cells may possess a stronger bone regenerative capability compared with Platelet-rich plasma (PRP), which contains enriched growth factors. The objective of this study was to evaluate the effects of human BMAC and PRP in combination with β-tricalcium phosphate (β-TCP) on promoting initial bone augmentation in an immunodeficient mouse model.