Clinical trial NCT02219113: Effectiveness and Safety of Autologous ADRC for Treatment of Degenerative Damage of Knee Articular Cartilage
Official title: Effectiveness and Safety of Intraarticular Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Degenerative Damage of Knee Articular Cartilage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Knee Joint Osteoarthritis
Keywords: Damage of articular cartilage
Cartilage degeneration
Intraarticular injection
ADRC
Adipose-derived regenerative cells
Adipose tissue
Stem cells
Lead sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Sponsor class: OTHER_GOV
Collaborators: name: I.M. Sechenov First Moscow State Medical University
First posted: 2014-08-18
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
timeFrame: 4 weeks after treatment
Secondary outcomes:
measure: Quality of life monitoring
timeFrame: Follow up to completion (up to 24 weeks after treatment)
measure: Knee pain intensity monitoring
timeFrame: Follow up to completion (up to 24 weeks after treatment)
measure: Changes in knee joint structures
timeFrame: Follow up to completion (up to 24 weeks after treatment)
measure: Changes in knee function
timeFrame: Follow up to completion (up to 24 weeks after treatment)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: 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
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University
name: Sergey V Ivannikov, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Ilya I Eremin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: