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

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation1 site in 1 country12 target enrollmentJuly 2014

ConditionsKnee Joint Osteoarthritis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Knee Joint Osteoarthritis
Sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Enrollment: 12
Locations: 1
Primary Endpoint: Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

April 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pain in the knee joint during more than a half day assessed by VAS (score more than 40 mm)
•At least three of the following 6 criteria: 50 years of age or older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, no warmth to the touch
•Patient is able to walk without assistance
•Patient is familiar with Participant information sheet
•Patient signed informed consent form
•Non-inclusion Criteria:
•Medical history of endoprosthetic knee replacement
•Medical history of lower extremity osteotomy
•Medical history of knee surgery (including arthroscopy) during preceding 1 year prior to enrollment
•Medical history of intraarticular injections during preceding 6 months prior to enrollment

Exclusion Criteria

•Patient's refusal from the further participation in trial
•Patient's refusal from compliance with the requirements of contraception during the participation in research
•Chronic kidney disease IV- V stages (creatinine clearance \< 30 mL/min estimated by Cockroft-Gault formula)
•Confirmed syphilis, HIV, hepatitis B or C infections
•Dropout Criteria:
•Pregnancy

Outcomes

Primary Outcomes

Number of serious adverse events (SAEs) and serious adverse reactions (SARs)

Time Frame: 4 weeks after treatment

Types, probability and severity of treatment emergent serious adverse events (SAEs) and serious adverse reactions (SARs)

Secondary Outcomes

Quality of life monitoring(Follow up to completion (up to 24 weeks after treatment))
Knee pain intensity monitoring(Follow up to completion (up to 24 weeks after treatment))
Changes in knee joint structures(Follow up to completion (up to 24 weeks after treatment))
Changes in knee function(Follow up to completion (up to 24 weeks after treatment))