NCT05507099

Stem Cell Study in Osteoarthritis of the Knee and Hip Joints

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Grigory Karmy · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Bone Marrow Aspirate, Lipoaspirate Concentrate	Autologous Cell Therapy.

Timeline

• Start date: 2022-08-23
• Primary completion: 2028-08-08
• Completion: 2028-08-08
• First posted: 2022-08-18
• Last updated: 2025-03-05

Locations

1 site across 1 country: Canada