NCT02469792

Effectiveness and Safety of Autologous ADRC for Treatment of Anterior Cruciate Ligament Partial Rupture

Effectiveness and Safety of Intraarticular Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Anterior Cruciate Ligament Partial Rupture

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Autologous adipose-derived regenerative cells (ADRC) will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. Patients will undergo knee arthroscopic surgery followed by one-time intraarticular ADRC administration (directly into anterior cruciate ligament). This is a single arm study with no control. All patients receive cell therapy.

Detailed description

Patients with verified diagnosis partial rupture of anterior cruciate ligament 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. Same day patients will undergo knee arthroscopic surgery followed by one-time intraarticular freshly isolated ADRC administration (directly into anterior cruciate ligament close to the rupture).

Conditions

• Anterior Cruciate Ligament Partial Rupture

Interventions

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

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2015-06-11
• Last updated: 2017-07-21

Locations

1 site across 1 country: Russia