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

July 19, 2017 updated by: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 121359
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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
  • Clinically significant abnormalities in results of laboratory tests
  • Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
  • Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
  • Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
  • Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
  • Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior lipoaspiration
  • Medical history of heterotopic ossifications
  • Patients prescribed for glycoprotein inhibitors treatment

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADRC injection
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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in knee function
Time Frame: Follow up to completion (up to 24 weeks after treatment)
Changes in knee function assessed by validated questionnaire: Knee Society Score (KSS)
Follow up to completion (up to 24 weeks after treatment)
Quality of life monitoring
Time Frame: Follow up to completion (up to 24 weeks after treatment)
Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS)
Follow up to completion (up to 24 weeks after treatment)
Knee pain intensity monitoring
Time Frame: Follow up to completion (up to 24 weeks after treatment)
Knee pain intensity assessed by Visual Analogue Scale (no pain=0; maximum pain=100 mm)
Follow up to completion (up to 24 weeks after treatment)
Changes in knee joint structures
Time Frame: Follow up to completion (up to 24 weeks after treatment)

Changes in knee joint structure assessed by:

  1. X-ray (joint space width, bone contour, presence of osteophytes and sclerosis);
  2. MRI (articular cartilage, osteophytes, bone marrow abnormality, meniscal integrity, synovial effusion/tissue, anterior and posterior cruciate ligaments, and medial and lateral collateral ligaments);
  3. Ultrasonography (effusion, synovial thickening or hypertrophy, cartilage parameters, vascularity, Baker's cysts, osteophytes, tendon and ligament abnormalities, meniscal changes, bursitis, erosions and panniculitis)
Follow up to completion (up to 24 weeks after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

I.M. Sechenov First Moscow State Medical University

Investigators

  • 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: Sergey V Ivannikov, Professor, I.M. Sechenov First Moscow State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

August 15, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RU-CCH-03-02-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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