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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

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 below

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I am between 18 and 95 years old.

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My average pain level is between moderate and severe.

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Your body weight is within a healthy range, and not excessively high.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90, 180, 360 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The primary endpoint is the change from the Baseline to the Day 360 in WOMAC pain subscale pain subscale

Secondary study objectives

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

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.

0 / 6Eligibility criteria met