Actively Recruiting
Stem Cell Study in Osteoarthritis of the Knee and Hip Joints
Led by Grigory Karmy · Updated on 2025-03-05
400
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this trial is to compare the effect of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate on pain reduction and functional improvement in the treatment of the knee and hip OA.
CONDITIONS
Official Title
Stem Cell Study in Osteoarthritis of the Knee and Hip Joints
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 to 95 years old
- Residents of Canada
- Written informed consent to participate in the study
- Willingness and ability to comply with study procedures and phone visits
- Average pain score between 4 and 9 on the Numeric Rating Scale over at least 5 daily measures
- Diagnosis of symptomatic knee or hip osteoarthritis for at least 12 weeks prior to screening
- Radiographic evidence of osteoarthritis (Kellgren-Lawrence Grade I to IV) within 1 year prior to screening
- Failed conservative treatment for more than 12 weeks with two or more therapies such as oral analgesics, physiotherapy, acupuncture, bracing, cortisone injections, hyaluronic acid injections, dextrose injections, or platelet-rich plasma injections
- Women of childbearing potential must use effective contraception from 14 days prior to baseline through 360 days after intervention
- Body mass index (BMI) less than or equal to 50 kg/m2
You will not qualify if you...
- Women who are pregnant or planning to become pregnant during the trial
- Women of childbearing potential not using highly effective contraception
- History of malignancy (except basal cell carcinoma) within 5 years prior to pre-screening
- Presence of retained rods, screws, or joint replacement in the joint to be injected
- History of autoimmune diseases including lupus and rheumatoid arthritis
- Arthroscopic or open surgery of the index joint within 6 months prior to screening
- Planned arthroscopic or open surgery of the index joint during the study period
- Intra-articular injections in the index joint within 3 months for corticosteroids or dextrose, or within 6 months for hyaluronic acid or platelet-rich plasma
- Use of systemic immunosuppressives, immunomodulators, or chemotherapy within 3 months prior to baseline
- Known hypersensitivity to lidocaine, epinephrine, or heparin
- History of coagulopathy
- Fever above 38.0°C at baseline
- Cutaneous infection at the lipoaspirate or bone marrow aspirate site or injection area at baseline
- Hemoglobin less than 10 g/L
- Platelet count less than 155x10^9/L
- Participation in another experimental drug or device study within 30 days of entry
- Any medical condition deemed unsuitable by the investigator
- Use of warfarin before screening with an INR greater than 3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Karmy Clinic
Brampton, Ontario, Canada, L6V 1B4
Actively Recruiting
Research Team
G
Grigory Karmy, MD
CONTACT
M
Maimuna F Ahmed, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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