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

NCT02219113 | Completed Phase 1

• 1 other identifier: RU-CCH-03-02-14
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Joint Osteoarthritis

Keywords

Damage of articular cartilage; Cartilage degeneration; Intraarticular injection; ADRC; Adipose-derived regenerative cells; Adipose tissue; Stem cells

Outcome Measures

Primary Outcomes (1)

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

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

  4 weeks after treatment

Secondary Outcomes (4)

• 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)

Study Arms (1)

ADRC injection

EXPERIMENTAL

Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected intraarticularly into knee joint.

Procedure: Arthroscopic surgery; Procedure: Liposuction; Device: ADRC isolation; Other: Intraarticular administration of autologous ADRC

Interventions

Arthroscopic surgery PROCEDURE

ADRC injection

Liposuction PROCEDURE

ADRC injection

ADRC isolation DEVICE

ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol

ADRC injection

Intraarticular administration of autologous ADRC OTHER

ADRC injection

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Secondary osteoarthritis of the knee joint: posttraumatic osteoarthritis (developed after clinically significant injury), intra-articular fractures, clinically significant varus or valgus deformities of lower limbs, septic arthritis, joint's inflammatory disorders, gout, advanced chondrocalcinosis, Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary synovial osteochondromatosis, osteonecrosis, hemophilia
• Patients prescribed for immunosuppressive treatment
• Medical history of systemic autoimmune and inflammatory diseases
• Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology
• Medical history of venous thromboembolism or estimated high risk of venous thromboembolism
• Patients prescribed for systemic corticosteroids or other medications treatment with proven impact on bone or cartilage tissue metabolism

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation: lead
• I.M. Sechenov First Moscow State Medical University: collaborator

Study Sites (1)

Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies

Moscow, 121359, Russia

Location

MeSH Terms

Interventions

Arthroscopy; Lipectomy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Plastic Surgery Procedures

Study Officials

• Sergey V Ivannikov, Professor

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

• Ilya I Eremin, MD, PhD

  Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 18, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

RU (1)