BMAC and LAC + LP-PRP for Osteoarthritis

(ABLE-OA Trial)

Recruiting in Toronto (>99 mi)

+2 other locations

Overseen By Shoba Singh

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University Health Network, Toronto

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

Disqualifiers: Rheumatoid arthritis, Hemophilia, Leukemia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: Single injection

148 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{2 3 4 5 6}

Research Team

Sowmya Viswanathan, PhD

Principal Investigator

University Health Network, Toronto

Christian Veillette, MD, MSc, FRCSC

Principal Investigator

University Health Network, Toronto

Christopher Kim, HBSc, MSc, MD, FRCSC, PhD(c)

Principal Investigator

University Health Network, Toronto

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.

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

Treatment Details

Interventions

• Bone Marrow Aspirate Concentrate (BMAC)
• Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP)

Trial Overview 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.

Participant Groups

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)

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Women's College Hospital

Collaborator

Trials

108

Recruited

43,700+

Cleveland Clinic Canada

Collaborator

Trials

1

Recruited

150+

Findings from Research

A systematic review of 27 Level I studies involving 2,396 patients found that platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) injections significantly improved knee osteoarthritis symptoms compared to hyaluronic acid (HA) injections, as measured by patient-reported outcome scores.

There were no significant differences in outcomes between PRP and BMAC, suggesting both treatments are equally effective for improving knee OA symptoms.

NCBI (Pubmed)

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. Belk, JW., Lim, JJ., Keeter, C., et al.[2023]

In a study involving 21 male rabbits with knee lesions, both platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) treatments showed improved articular surface remodeling compared to a control group, indicating their potential effectiveness in treating knee injuries.

The use of regenerative therapies like PRP and BMAC after surgery can enhance joint outcomes and reduce degeneration, suggesting they should be considered as valuable adjunct treatments in orthopedic practice.

NCBI (Pubmed)

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. Lăzărescu, AE., Văduva, AO., Hogea, GB., et al.[2021]

In a study of 89 patients with knee osteoarthritis, treatments using platelet-rich plasma (PRP), bone marrow aspirate concentrate (BMAC), and adipose-derived mesenchymal stem cells (MSC) all showed significant improvements in knee function over time, as measured by various clinical scores.

There was no significant difference in effectiveness among the three treatment types, suggesting that all three are viable, cost-effective options for managing knee osteoarthritis.

NCBI (Pubmed)

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. Estrada, E., Décima, JL., Rodríguez, M., et al.[2022]

In a case study of 3 females with knee osteoarthritis, the combination of a single bone marrow aspiration concentrate (BMAC) injection followed by a platelet-rich plasma (PRP) injection led to improvements in pain and functionality scores for all patients.

These results suggest that using BMAC and PRP together may enhance pain relief and functional status, potentially improving the quality of life for individuals suffering from knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow aspiration concentrate and platelet-rich plasma in the treatment of knee osteoarthritis: A report of three cases. Subaşı, V., Ekiz, T.[2019]

In a randomized controlled trial involving 90 participants with knee osteoarthritis, both autologous platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMC) showed significant improvements in pain and function over 24 months, with no significant differences between the two treatments.

Both PRP and BMC led to sustained improvements in patient-reported outcomes, plateauing at 3 months and maintained through 24 months, indicating that neither treatment was superior to the other for managing knee osteoarthritis.

NCBI (Pubmed)

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. Anz, AW., Plummer, HA., Cohen, A., et al.[2022]

Bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) both significantly enhance initial bone regeneration when combined with β-tricalcium phosphate (β-TCP) in an immunodeficient mouse model, with new bone formation observed at 7.6% and 7.2% respectively, compared to only 2.7% in the control group.

The study found that while both BMAC and PRP increased the number of bone cells and showed similar efficacy in promoting bone growth, the differences in effectiveness between the two treatments were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo comparison of the bone regeneration capability of human bone marrow concentrates vs. platelet-rich plasma. Zhong, W., Sumita, Y., Ohba, S., et al.[2022]

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]

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]

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]

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]

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]

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]