A Study to Evaluate the Safety, and Efficacy of Minimally Manipulated Autologous Bone Marrow Aspirate to Treat Knee Osteoarthritis in Patients

NCT05288725 Phase 1/Phase 2 UNKNOWN

The study is a multicentered, randomized, double-blinded, placebo-controlled study conducted on the unilateral knee of 120 patients. The study compares the effectiveness of an injection of a mesenchymal stem cell preparation from autologous bone marrow aspirate (BMA) to a corticosteroid control for knee osteoarthritis. WOMAC, VAS pain scores, and MRI will be used for assessment. The study will be conducted at 3 sites in the United States.

Details

Lead sponsor	Next Generation Regenerative Medicine LLC
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	120
Start date	2022-08
Completion	2024-12

Conditions

• Osteoarthritis, Knee

Interventions

• Bone Marrow Derived MSCs
• Corticosteroid
• Bone Marrow Aspirate

Primary outcomes

• Change from Baseline Western Ontario McMaster University Osteoarthritis Index (WOMAC) at 3 months — 3 months
  The Western Ontario and McMaster Universities Osteoarthritis Index is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. The minimum clinically important difference (MCID) for this parameter is ≥ 10.
• Change from Baseline Western Ontario McMaster University Osteoarthritis Index (WOMAC) at 6 months — 6 months
  The Western Ontario and McMaster Universities Osteoarthritis Index is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. The minimum clinically important difference (MCID) for this parameter is ≥ 10.
• Change from Baseline Western Ontario McMaster University Osteoarthritis Index (WOMAC) at 12 months — 12 months
  The Western Ontario and McMaster Universities Osteoarthritis Index is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. The minimum clinically important difference (MCID) for this parameter is ≥ 10.
• Change from Baseline Visual Analog Score (VAS) at 3 months — 3 months
  The pain VAS is a unidimensional scale of pain that is widely used and well validated in diverse groups of adult patients. The horizontal scale will be anchored by "no pain" (0) with "worst imaginable pain" (10) being at the opposite extreme. The minimum clinically important difference (MCID) for this measure is VAS ≥ 2
• Change from Baseline Visual Analog Score (VAS) at 6 months — 6 months
  The pain VAS is a unidimensional scale of pain that is widely used and well validated in diverse groups of adult patients. The horizontal scale will be anchored by "no pain" (0) with "worst imaginable pain" (10) being at the opposite extreme. The minimum clinically important difference (MCID) for this measure is VAS ≥ 2
• Change from Baseline Visual Analog Score (VAS) at 12 months — 12 months
  The pain VAS is a unidimensional scale of pain that is widely used and well validated in diverse groups of adult patients. The horizontal scale will be anchored by "no pain" (0) with "worst imaginable pain" (10) being at the opposite extreme. The minimum clinically important difference (MCID) for this measure is VAS ≥ 2

Countries

United States