NCT01799876

Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

Autologous Cell Therapy Enhancement of Microfracture Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Fondren Orthopedic Group L.L.P. · Academic / Other
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.

Detailed description

Participation in this study will allow the surgical team to remove a small amount of fat (20 to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that will be processed to remove regenerative cells, which will then inserted into the knee to the damaged cartilage. These cells may encourage healing at the surgical site, although whether or how much they encourage healing is unknown. Determining whether such improved healing occurs is the purpose of this study. Some patients will have the fat removed and cells inserted in their knee, and other patients will not have the fat removed or cells inserted. To which group patients are assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients. Participation will require attending regularly scheduled postoperative visits, having 3 MRI tests, and answering a short survey. No additional visits other beyond those normally scheduled for postsurgical care are required.

Conditions

• Articular Cartilage Defect Grade III or IV of the Knee

Interventions

Type	Name	Description
PROCEDURE	Autologous Cell
PROCEDURE	Standard microfracture arthroscopic surgery

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-08-01
• Completion: 2017-08-01
• First posted: 2013-02-27
• Last updated: 2019-01-10

Locations

1 site across 1 country: United States