A Phase 2, Randomized Study to Compare Bone Marrow Aspirate Versus Lipoaspirate Concentrate Autologous Cell Therapy for the Treatment of the Knee and Hip Osteoarthritis in Adults

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
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• 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 the study procedures and phone visit schedules and ability to follow verbal and written instruction

• The NRS for at least 5 daily measures will be used to calculate the average score. An average NRS pain score 4-9 (moderate to severe pain).

• Diagnosis of symptomatic knee or hip osteoarthritis for at least 12 weeks prior to screening based on an X-ray performed within 1 year prior to screening period.

• Radiographic evidence of OA of the index knee or hip (Kellgren-Lawrence Grade I to IV) within 1 year prior to screening or during the screening period.

• Failed conservative treatment for more than 12 weeks before the screening, meaning that pain persists for more than 12 weeks after the patient tried two or more of the following medication or interventions in that period.

‣ oral analgesics, including over-the-counter medications and supplements,

⁃ physiotherapy

⁃ acupuncture

⁃ bracing

⁃ cortisone injections,

⁃ hyaluronic acid injections,

⁃ dextrose injections (prolotherapy)

⁃ platelet-rich plasma injections

• Women of childbearing potential must use an effective method of contraception from 14 days prior to baseline visit to 360 days after intervention. Effective birth control considered for this trial are total abstinence; consistent use of birth control pills; injectable birth control methods; intrauterine device placement; and tubal ligation or male partner with vasectomy; diaphragm with contraceptive jelly or condom with contraceptive foam.This does not apply to male and postmenopausal women.

⁃ Body mass index (BMI) ≤ 50 kg/m2

Locations
Other Locations
Canada
Karmy Clinic
RECRUITING
Brampton
Contact Information
Primary
Grigory Karmy, MD
grigmed66@gmail.com
905 278 5158
Backup
Maimuna F Ahmed, MBBS
maimuna@karmyclinic.com
905 278 5158
Time Frame
Start Date: 2022-08-23
Estimated Completion Date: 2028-08-08
Participants
Target number of participants: 400
Treatments
Active_comparator: Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
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.
Active_comparator: Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate
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.
Related Therapeutic Areas
Sponsors
Leads: Grigory Karmy

This content was sourced from clinicaltrials.gov