NCT02827851

Autologous Stromal Vascular Fraction of Cells for Treatment of Knee Articular Cartilage Dystrophy

Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal Vascular Fraction of Cells for Treatment of Knee Articular Cartilage Dystrophy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• 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

Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly 4 weeks after arthroscopic debridement. All patients will receive cell therapy.This is a single arm study with no control.

Detailed description

Patients undergone arthroscopic debridement for knee osteoarthritis will be subjected to abdominal liposuction under local anaesthesia. Harvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution. Isolated SVF will be administered in a single dose into anterior part of knee joint cavity 28 days after arthroscopy.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Liposuction
OTHER	SVF isolation	SVF will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution.
OTHER	Intraarticular administration of autologous SVF

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-05-01
• Completion: 2018-11-01
• First posted: 2016-07-11
• Last updated: 2017-07-21

Locations

4 sites across 1 country: Russia