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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.
The primary objective is to compare of magnitude and duration of pain relief of intra-articular injections with Lipoaspirate Concentrate vs Bone Marrow Aspirate.
The secondary objective is to compare the effect of Lipoaspirate Concentrate vs Bone Marrow Aspirate intra-articular injections on functional improvement, stiffness, global impression of change, and consumption of analgesic medication.
The exploratory objective is to explore the safety and the general tolerability of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate | Active Comparator | 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. |
|
| Hip Arm randomized to Lipoaspirate Concentrate and Bone Marrow Aspirate | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Aspirate, Lipoaspirate Concentrate | Biological | Autologous Cell Therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the change from the Baseline to the Day 360 in WOMAC pain subscale pain subscale | 360 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Days 90, 180 in WOMAC pain subscale | 90, 180 days | |
| Change from Baseline to Days 90, 180, and 360 in WOMAC stiffness subscale | 90, 180, 360 days | |
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Inclusion Criteria:
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.
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grigory Karmy, MD | Contact | 905 278 5158 | grigmed66@gmail.com | |
| Maimuna F Ahmed, MBBS | Contact | 905 278 5158 | maimuna@karmyclinic.com |
| Name | Affiliation | Role |
|---|---|---|
| Grigory Karmy, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmy Clinic | Recruiting | Brampton | Ontario | L6V 1B4 | Canada |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Change from Baseline to Days 90, 180, and 360 in WOMAC function subscale |
| 90, 180, 360 days |
| Change from Baseline to Days 90, 180, and 360 in total WOMAC score | 90, 180, 360 days |
| Change from Baseline to Days 90, 180, and 360 in Patient's Global Impression of Changes (PGIC) | 90, 180, 360 days |
| Change in average weekly consumption of analgesic medications from Baseline to Day 90, 180, and 360 | 90, 180, 360 days |