BMAC and LAC + LP-PRP for Osteoarthritis

(ABLE-OA Trial)

Recruiting at 2 trial locations

Overseen By Christian Veillette, MD, MSc, FRCSC

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for knee osteoarthritis, a condition that causes chronic knee pain. One treatment uses bone marrow cells (Bone Marrow Aspirate Concentrate, or BMAC), while the other combines fat cells and a special type of blood plasma (Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma, or LAC + LP-PRP). The goal is to determine if either treatment can reduce knee pain and improve knee function. Individuals with ongoing knee pain and discomfort in one knee who haven't recently used certain knee injections might be suitable candidates for this trial. As a Phase 2, Phase 3 trial, the study measures the treatments' effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in knee osteoarthritis treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, 95% of patients reported complete pain relief one year after receiving Bone Marrow Aspirate Concentrate (BMAC) injections. The same study found that patients experienced significant improvements in movement and function. Another study examined BMAC treatments and confirmed their safety, also noting reductions in pain and enhancements in knee function.

For the Lipoaspirate Micronized and Leukocyte-Poor Platelet-Rich Plasma (LAM + LP-PRP) treatment, a study showed that three injections over time led to similar improvements in knee function, suggesting effectiveness over the course of a year.

Both treatments have been tested in other studies and have demonstrated safety. They are generally well-tolerated by patients. However, like any medical treatment, side effects or complications may occur, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for osteoarthritis because they offer innovative approaches that differ from traditional methods like NSAIDs, corticosteroids, or joint replacement surgery. The Bone Marrow Aspirate Concentrate (BMAC) treatment is unique because it uses stem cells from the patient's own bone marrow, which could help regenerate cartilage and reduce inflammation. The Lipoaspirate Micronized combined with Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP) offers a dual approach: it harnesses growth factors from platelets and regenerative cells from fat tissue to potentially enhance joint healing and pain relief. These treatments are particularly promising as they aim to repair and regenerate joint tissue, rather than just alleviate symptoms, offering a more comprehensive solution for osteoarthritis sufferers.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

In this trial, participants will receive either Bone Marrow Aspirate Concentrate (BMAC) or Lipoaspirate combined with Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP) as separate treatment options. Research has shown that BMAC can provide short- to mid-term relief and improve movement for people with knee osteoarthritis, with some benefits lasting up to four years. For LAC + LP-PRP, studies indicate that patients experience less pain and better movement after injections, with improvements usually noticed within 24 weeks and lasting up to a year. Both treatments show promise for managing knee osteoarthritis symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Christian Veillette, MD, MSc, FRCSC

Principal Investigator

University Health Network, Toronto

Sowmya Viswanathan, PhD

Principal Investigator

University Health Network, Toronto

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

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38929594/

Effectiveness and Complications of Bone Marrow Aspirate ... This study retrospectively evaluated data from 231 patients (285 knees) with knee OA treated with BMAC articular injection at a single center ...

2. nature.com nature.com/articles/s41598-024-51410-2

Intra-articular injection of bone marrow aspirate ... In summary, this is the first study on BMAC injections into 37 osteoarthritic knees with a 4-year follow up showing significant improvements in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806324000938

Meta-Analysis Platelet-Rich Plasma, Bone Marrow Aspirate ... At a minimum 6-month follow-up, PRP demonstrated significantly improved pain and function for patients with knee osteoarthritis compared to placebo.

4. mdpi.com mdpi.com/1648-9144/61/5/853

Bone Marrow Aspirate Concentrate (BMAC) for Knee ... Clinical evidence suggests that BMAC provides short- to mid-term symptomatic relief and functional improvement, with some studies indicating a potential to ...

5. biologicortho.com biologicortho.com/index.php/BiologicOrtho/article/view/71

A REVIEW OF BONE MARROW ASPIRATE ... The literature reviewed indicates that the intraarticular injection of BMAC warrants additional investigation in treating mild to severe osteoarthritis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12113016/

Bone Marrow Aspirate Concentrate (BMAC) for Knee ... [24] found that 95% of patients achieved complete pain relief after one year of BMAC treatment, with significant improvements in functional outcomes (p < 0.0001) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04716803

Bone Marrow Aspirate Concentrate (BMAC)Treatment for ... The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11208346/

Safety and Efficacy of Bone-Marrow Aspirate Concentrate ... The results from this review demonstrated that administration of BMAC is safe and potentially efficacious in terms of reducing pain, improving function and ...

9. mdpi.com mdpi.com/1648-9144/60/6/977

Effectiveness and Complications of Bone Marrow Aspirate ... This study aimed to identify the effectiveness and potential complications on the harvest site and knee of bone marrow aspirate concentrate (BMAC) treatment