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

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation1 site in 1 country12 target enrollmentJune 2015

ConditionsAnterior Cruciate Ligament Partial Rupture

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Anterior Cruciate Ligament Partial Rupture
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)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

December 2018

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

•Patient suffers from partial rupture of anterior cruciate ligament (confirmed by MRI or knee arthroscopic surgery)
•Clinically significant knee instability (positive anterior drawer test, pivot shift test, and Lachman test)
•Patient is familiar with Participant information sheet
•Patient signed informed consent form
•Non-inclusion Criteria:
•Knee osteoarthritis grade III and grade IV
•Medical history of autoimmune diseases
•Patients prescribed for immunosuppressive treatment
•Contraindications to the general or local anesthesia or medical history of allergic reactions to anesthetics
•Subcompensated or decompensated forms of chronic diseases of internal organs

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:
•Complete anterior cruciate ligament rupture confirmed by knee arthroscopic surgery
•Pregnancy

Outcomes

Primary Outcomes

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

Time Frame: 2 weeks after treatment

Secondary Outcomes

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