← Back to Search

Stem Cell Therapy

Stem Cell Injections for Osteoarthritis

Phase 2
Recruiting
Led By Grigory Karmy, MD
Research Sponsored by Grigory Karmy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 18 to 95 years old
Residents of Canada
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90, 180, 360 days
Awards & highlights

Summary

This trial is comparing the effects of two different injections on reducing pain and improving function for people with knee or hip OA.

Who is the study for?
This trial is for Canadian residents aged 18-95 with moderate to severe knee or hip osteoarthritis pain, who've tried treatments like physiotherapy, injections, and oral painkillers. They must be able to follow the study plan and have a BMI ≤ 50 kg/m2. People with autoimmune diseases, allergies to certain anesthetics or anticoagulants, or metal implants in the affected joint cannot join.Check my eligibility
What is being tested?
The study tests if one injection of Lipoaspirate Concentrate (fat-derived cells) is more effective than Bone Marrow Aspirate (bone marrow-derived cells) at reducing pain and improving function in osteoarthritic knees and hips.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, swelling, infection risk increase due to the procedure itself rather than from the substances injected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 95 years old.
Select...
My average pain level is between moderate and severe.
Select...
Your body weight is within a healthy range, and not excessively high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90, 180, 360 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90, 180, 360 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary endpoint is the change from the Baseline to the Day 360 in WOMAC pain subscale pain subscale
Secondary outcome measures
Change from Baseline to Days 90, 180 in WOMAC pain subscale
Change from Baseline to Days 90, 180, and 360 in Patient's Global Impression of Changes (PGIC)
Change from Baseline to Days 90, 180, and 360 in WOMAC function subscale
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow AspirateActive Control1 Intervention
The subjects will be randomized to one of the treatment groups separately for the knee and hip arms of the study. Groups C will receive a single intra-articular injection with lipoaspirate concentrate to the hip and Group D will receive a single intra-articular injection with bone marrow aspirate.
Group II: Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow AspirateActive Control1 Intervention
The Subjects will be randomized to one of the treatment groups separately for the knee and hip arms of the study. Group A will receive a single intra-articular injection with lipoaspirate concentrate to the knee and Group B will receive a single intra-articular injection with bone marrow aspirate concentrate.

Find a Location

Who is running the clinical trial?

Grigory KarmyLead Sponsor
Grigory Karmy, MDPrincipal InvestigatorMcMaster University

Media Library

Bone Marrow Aspirate (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05507099 — Phase 2
Osteoarthritis Research Study Groups: Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate, Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
Osteoarthritis Clinical Trial 2023: Bone Marrow Aspirate Highlights & Side Effects. Trial Name: NCT05507099 — Phase 2
Bone Marrow Aspirate (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05507099 — Phase 2
Osteoarthritis Patient Testimony for trial: Trial Name: NCT05507099 — Phase 2
~267 spots leftby Aug 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top