Your session is about to expire
← 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 up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking pain medication that can be bought without a prescription.I have received platelet-rich plasma injections.I am currently undergoing or have completed physiotherapy.I have received hyaluronic acid injections.Your body weight is within a healthy range, and not excessively high.My average pain level is between moderate and severe.I have metal rods, screws, or a joint replacement in the joint needing injection.I am receiving or have received dextrose injections.I am between 18 and 95 years old.More information is needed to understand what this criterion is referring to. Can you please provide additional context or details?I have undergone acupuncture.I have received cortisone injections.
Research Study Groups:
This trial has the following groups:- Group 1: Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
- Group 2: Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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: NCT05507099 — Phase 2