NCT02219113

Effectiveness and Safety of Autologous ADRC for Treatment of Degenerative Damage of Knee Articular Cartilage

Effectiveness and Safety of Intraarticular Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Degenerative Damage of Knee Articular Cartilage

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation · Other Government
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. ADRC will be administered one-time intraarticularly. This is a single arm study with no control. All patients receive cell therapy.

Detailed description

Patients with verified diagnosis knee joint osteoarthritis (degenerative damage of knee articular cartilage) will undergo knee arthroscopic debridement. 28 days later patients will will undergo liposuction from front abdominal wall under local anesthesia. After that autologous ADRC will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from harvested adipose tissue. Extracted ADRC will be administered one-time intraarticularly.

Conditions

• Knee Joint Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic surgery
PROCEDURE	Liposuction
DEVICE	ADRC isolation	ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
OTHER	Intraarticular administration of autologous ADRC

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-12-01
• Completion: 2017-04-01
• First posted: 2014-08-18
• Last updated: 2017-07-21

Locations

1 site across 1 country: Russia