BMAC and LAC + LP-PRP for Osteoarthritis (ABLE-OA Trial)

Phase 2 & 3

Waitlist Available

Led By Sowmya Viswanathan, PhD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-injection) and 3, 6 and 12 months (post-injection)

Summary

This trial is testing whether two minimally manipulated autologous cellular preparations can help treat knee osteoarthritis. The cellular preparations are bone marrow aspirate concentrate (BMAC) injection and combined lipoaspirate concentrate (LAC) and leukocyte poor (LP) platelet-rich plasma (PRP) injections. The trial will collect patient-reported outcome measures and blood, synovial fluid, and urine samples.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at injection sites; risk of infection; allergic reactions; temporary increase in inflammation leading to swelling or pain; bruising or bleeding due to needle insertion. Since these are autologous treatments using patients' own cells there might be fewer side effects compared to foreign substances.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-injection) and 3, 6 and 12 months (post-injection)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-injection) and 3, 6 and 12 months (post-injection)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-injection) and 3, 6 and 12 months (post-injection) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Level Changes. Differences in response rates between groups (treatments vs placebos) at 6-months (end of study) compared to baseline. Response is based on an improvement of 2 units or more in the Numeric Pain Rating Scale (NPRS).

Secondary study objectives

Additional Pain Level Changes. Mean KOOS pain subscale change score at 6 months relative to baseline in treatment groups compared to placebo groups.

Additional Pain Level Changes. Mean NPRS subscale change score at 6 months relative to baseline in treatment groups compared to placebo groups.

Functional Changes. Differences in mean change of Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) subscale scores between groups (treatments vs placebos) at 6-months (end of study) compared to baseline.

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Other study objectives

Levels of soluble/secreted factors (FGF2, G-CSF, IL-1RA/IL-1F3, IL-4, IL-10, PDGF-BB, VEGF) in the BMA, LAM and LP-PRP cellular preparations in treatment groups only.

Synovitis

Percentages of hematopoietic, endothelial, and stromal cells in the BMA and LAM cellular preparations in treatment groups only.

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: For STUDY 2 (ARM B): Lipoaspirate Micronized + Leukocyte-Poor Platelet-Rich Plasma (LAM + LP-PRP)Experimental Treatment1 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 Treatment1 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 InjectionPlacebo Group1 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 InjectionPlacebo Group1 Intervention

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

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