NCT05553132

A Study of REcycled CartiLage Auto/Allo IMplantation to Treat and Repair Focal Hip Cartilage Defects

Hip RECLAIM: A Phase I Safety and Feasibility Trial of REcycled CartiLage Auto/Allo IMplantation for the Treatment and Repair of Focal Hip Cartilage Defects

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Daniel B. F. Saris · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study it to gather information on the safety and side effects of treating cartilage defects with autologous cartilage cells mixed with allogeneic adipose-derived mesenchymal stem cells (AMSCs) in a fibrin glue.

Conditions

• Cartilage Defect

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Autologous Chondrocytes in their Pericellular Matrix (Chondrons) Coimplanted with Allogeneic Adipose-Derived Mesenchymal Stromal Cells (AMSCs) in a Fibrin Glue Carrier	Cartilage cells are being used from the rim of the defect in the hip and recycled to help make new cartilage in the hip. There are not enough cartilage cells to fill the defect so cartilage cells need to be mixed with MSCs. MSCs or Mesenchymal Stem Cells are naturally occurring cells that provide growth factors and cell signals that play a role in tissue repair. MSCs can be found in bone marrow and in the fatty tissues (i.e., area under the skin of the belly or breast) of patients. Fibrin glue is a product made from the naturally occurring compounds in blood which cause clotting. This glue hardens into a gel-like substance into which cells such as cartilage cells (chondrons) and AMSCs can be placed.

Timeline

• Start date: 2023-08-08
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-09-23
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study