NCT05288725

Mesenchymal Stem Cell Therapy for Knee Osteoarthritis

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Next Generation Regenerative Medicine LLC · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Osteoarthritis (OA) is the most common form of arthritis in the knee that affects millions of adults throughout the world and is the leading cause of disability. It is a degenerative type of arthritis that occurs most often in patients, as the cartilage in the knee joint gradually wears away. As the cartilage wears away, it becomes frayed and rough, and the protective space between the bones decreases. This can result in bone rubbing on bone and produce painful bone spurs. The patient experiences pain that worsens over time. Although current surgical therapeutic procedures to cartilage repair are clinically useful, they cannot restore a normal articular surface, and in many cases, resulted in the growth of inferior quality fibrocartilage. Therefore, techniques and practices have been developed to collect minimally manipulated bone marrow aspirate (BMA), that contains Bone Marrow Derived Mesenchymal Stem Cells (BMDMSCs) and other endogenous acellular components, from knee OA patients for autologous transplantation in the treatment of their knee OA. Participants will be randomized to study arms to receive a BMA injection to the intra-articular knee, subchondral knee, both intra-articular and subchondral knee, or to receive a corticosteroid injection to the knee. A corticosteroid injection is currently the standard of care for osteoarthritis patients having knee pain. All participants will undergo a procedure. Participants will be blinded as to whether they receive a BMA injection or a corticosteroid injection.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	Bone Marrow Derived MSCs	Autologous bone marrow aspirate (BMA) is an orthobiologic injection used in knee osteoarthritis therapy. Bone marrow aspirate is harvested from the posterior superior iliac crest (PSIS) of the spine using the Marrow Cellutions kit. BMA will be injected into the knee using ultrasound guidance.
DRUG	Corticosteroid	The corticosteroid is prepared in a 10 ml syringe by combining 1-2 mL Kenalog \[40 mg/dL\], 6-8 mL sterile normal saline, 3-4 mL Ropivicaine 1%.
DEVICE	Bone Marrow Aspirate	The Marrow Cellutions kit is an FDA approved device for harvesting bone marrow aspirate.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2022-03-21
• Last updated: 2022-03-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study