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Cell Therapy
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)
Awards & highlights
ABLE-OA Trial 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.Check my eligibility
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.See study design
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.
ABLE-OA Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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.
+3 moreOther outcome measures
Levels of soluble/secreted factors (FGF2, G-CSF, IL-1RA/IL-1F3, IL-4, IL-10, PDGF-BB, VEGF) in the BMAC, LAC and PRP cellular preparations in treatment groups only.
Synovitis
Percentages of hematopoietic, endothelial, and stromal cells in the BMAC and LAC cellular preparations in treatment groups only.
+2 moreABLE-OA Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: For STUDY 2 (ARM B): Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP)Experimental Treatment1 Intervention
This group will undergo a blood collection/lipoaspiration and receive an ultrasound guided intra-articular injection of LAC (a single dose of concentrated cell suspension of 9 mL or less) followed by LP-PRP (a single dose of concentrated cell suspension of 2 mL or less)
Group II: For STUDY 1 (ARM A): Bone Marrow Aspirate Concentrate (BMAC)Experimental Treatment1 Intervention
This group will undergo a bone marrow aspiration and receive an ultrasound guided intra-articular injection of BMAC (a single dose of concentrated cell suspension of 9 mL or less)
Group III: For STUDY 2 (ARM D): Saline InjectionPlacebo Group1 Intervention
This group will undergo a blood collection/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)
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,342 Total Patients Enrolled
4 Trials studying Osteoarthritis
1,610 Patients Enrolled for Osteoarthritis
Women's College HospitalOTHER
100 Previous Clinical Trials
38,655 Total Patients Enrolled
1 Trials studying Osteoarthritis
34 Patients Enrolled for Osteoarthritis
Cleveland Clinic CanadaUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My knee is currently infected.I have long-term pain in one knee.My knee bends inward or outward more than 10 degrees.I have used steroids for a chronic condition in the last 3 months.I had knee surgery through a small incision within the last 6 months.I've had an anti-inflammatory knee injection in the last 6 months.I have poor blood or fluid flow in my leg.My knee X-ray shows moderate to severe arthritis.I have been diagnosed with a specific type of arthritis or related condition.I've been using opioids daily for 3 months and can't stop anti-platelet meds.I am 30 years old or older.I am currently immunosuppressed or have an active infection.I have leukemia or blood cancer with spreading cancer cells or am undergoing/planning chemotherapy.I have a knee injury causing pain or swelling.I couldn't undergo the fat removal procedure successfully due to intolerance.
Research Study Groups:
This trial has the following groups:- Group 1: For STUDY 2 (ARM B): Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP)
- Group 2: For STUDY 1 (ARM A): Bone Marrow Aspirate Concentrate (BMAC)
- Group 3: For STUDY 2 (ARM D): Saline Injection
- Group 4: For STUDY 1 (ARM C): Saline Injection
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05517434 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment centers still enrolling patients for this study?
"The study in question is not recruiting patients at this time, as per the latest update on clinicaltrials.gov. 722 other trials are currently active and recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
Pennsylvania
Ontario
How old are they?
18 - 65
65+
What site did they apply to?
Cleveland Clinic Canada
Toronto Western Hospital, University Health Network
Women's College Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
I have tried 3 different drugs and exercise and did not work. I am hoping to improve my quality of life quality by this trial.
PatientReceived 1 prior treatment
I would like to meet with a real person before I consent. I do have Osteoarthritis for sure…but do not know the baseline terms you use. I have already had a left knee replacement. My left knee is due for surgery according to a doctor at Mt. Sinai. I have just had a bone scan and an MIR.
PatientReceived no prior treatments
I had torn quads which were repaired in October 2021 and while the surgery was successful, I have osteoarthritis in my right knee which has been aggravated by compensating for the prior surgery. I truly do not want a knee replacement and would like to try alternate therapies to help with my pain level.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long is this clinical tests? What are my chances of getting selected? Will I be able to get full relief or at least substantial pain relief to walk and live independently?
PatientReceived 2+ prior treatments
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