Cell Therapy
Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP): Minimally manipulated, concentrated autologous cellular preparations for Osteoarthritis
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
Unilateral, symptomatic, chronic knee pain
Unilateral, symptomatic, chronic knee pain
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline (pre-injection) and 3, 6 and 12 months (post-injection)
Awards & highlights
Study 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.
Eligible Conditions
- Osteoarthritis of the Knee
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have long-term pain in one knee that causes symptoms.
Select...
You have long-lasting pain in one knee that causes noticeable symptoms.
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 moreTrial 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 site
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,420 Previous Clinical Trials
482,062 Total Patients Enrolled
3 Trials studying Osteoarthritis
1,555 Patients Enrolled for Osteoarthritis
Women's College HospitalOTHER
97 Previous Clinical Trials
38,557 Total Patients Enrolled
1 Trials studying Osteoarthritis
34 Patients Enrolled for Osteoarthritis
Cleveland Clinic CanadaUNKNOWN
Christian Veillette, MD, MSc, FRCSCStudy Director
University Health Network, TorontoSowmya Viswanathan, PhDPrincipal Investigator
University Health Network, Toronto1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Osteoarthritis
12 Patients Enrolled for Osteoarthritis
Media Library
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?
65+
18 - 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.
Patient
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.
Patient
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?
Patient