Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP): Minimally manipulated, concentrated autologous cellular preparations for Osteoarthritis, Knee

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cleveland Clinic Canada, Toronto, Canada
Osteoarthritis, Knee+1 More
Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP): Minimally manipulated, concentrated autologous cellular preparations - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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. Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP): A minimally manipulated, concentrated autologous cellular preparation, that has previously been approved by the FDA for a different condition, is now being used to treat Osteoarthritis, Knee.

Eligible Conditions

  • Osteoarthritis, Knee

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: baseline (pre-injection) and 3, 6 and 12 months (post-injection)

6 months (post-injection)
Treatment Satisfaction. Percent satisfaction at 6 months in treatment groups compared to placebo groups.
Month 12
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.
Health-Related Quality of Life Changes. Mean utility and EuroQol-Visual Analogue Scale (EQ-VAS) change scores at 6 months (end of study) relative to baseline in treatment groups compared to placebo groups.
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).
Safety. Proportion of cumulative adverse events (AEs) at 6 months post-injection in treatment groups compared to placebo groups.
Month 6
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.
Local and systemic levels of immune cells and inflammatory cytokines and chemokines in synovial fluid and blood in treatment groups and placebo groups.
Percentages of hematopoietic, endothelial, and stromal cells in the BMAC and LAC cellular preparations in treatment groups only.
Systemic levels of inflammatory and catabolic factors in synovial fluid, blood and urine in treatment groups and placebo groups.
Total nucleated cell count (TNC) in the BMAC and LAC cellular preparations in treatment groups only.

Trial Safety

Trial Design

4 Treatment Groups

For STUDY 2 (ARM B): Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + L...
1 of 4
For STUDY 1 (ARM A): Bone Marrow Aspirate Concentrate (BMAC)
1 of 4
For STUDY 2 (ARM D): Saline Injection
1 of 4
For STUDY 1 (ARM C): Saline Injection
1 of 4
Experimental Treatment
Non-Treatment Group

148 Total Participants · 4 Treatment Groups

Primary Treatment: Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP): Minimally manipulated, concentrated autologous cellular preparations · Has Placebo Group · Phase 2 & 3

For STUDY 2 (ARM B): Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP)
Biological
Experimental Group · 1 Intervention: Lipoaspirate + Leukocyte-Poor Platelet-Rich Plasma (LAC + LP-PRP): Minimally manipulated, concentrated autologous cellular preparations · Intervention Types: Biological
For STUDY 1 (ARM A): Bone Marrow Aspirate Concentrate (BMAC)
Biological
Experimental Group · 1 Intervention: Bone Marrow Aspirate Concentrate (BMAC): Minimally manipulated, concentrated autologous cellular preparation · Intervention Types: Biological
For STUDY 2 (ARM D): Saline Injection
Other
PlaceboComparator Group · 1 Intervention: Saline (Placebo Comparator for LAC+LP-PRP) · Intervention Types: Other
For STUDY 1 (ARM C): Saline Injection
Other
PlaceboComparator Group · 1 Intervention: Saline (Placebo Comparator for BMAC) · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (pre-injection) and 3, 6 and 12 months (post-injection)
Closest Location: Cleveland Clinic Canada · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2011First Recorded Clinical Trial
1 TrialsResearching Osteoarthritis, Knee
1 CompletedClinical Trials

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,353 Previous Clinical Trials
471,980 Total Patients Enrolled
1 Trials studying Osteoarthritis, Knee
1,200 Patients Enrolled for Osteoarthritis, Knee
Women's College HospitalOTHER
91 Previous Clinical Trials
36,438 Total Patients Enrolled
Cleveland Clinic CanadaUNKNOWN
Sowmya Viswanathan, PhDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Osteoarthritis, Knee
12 Patients Enrolled for Osteoarthritis, Knee
Christian Veillette, MD, MSc, FRCSCStudy DirectorUniversity Health Network, Toronto

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have signed a written consent for study participation.
You are 30 years of age or older.
You are willing and able to comply with study procedures and visit schedules and able to follow oral and written instructions.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.