Autologous Stromal Vascular Fraction of Cells for Treatment of Knee Articular Cartilage Dystrophy

Knee Osteoarthritis Clinical Trial

Official title:

Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal Vascular Fraction of Cells for Treatment of Knee Articular Cartilage Dystrophy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02827851
• Other study ID #: RU-???-03-01-16
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: June 24, 2016
• Last updated: July 19, 2017
• Start date: May 2016
• Est. completion date: November 2018

Study information

• Verified date: July 2017
• Source: Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly 4 weeks after arthroscopic debridement. All patients will receive cell therapy.This is a single arm study with no control.

Description:

Patients undergone arthroscopic debridement for knee osteoarthritis will be subjected to abdominal liposuction under local anaesthesia. Harvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution. Isolated SVF will be administered in a single dose into anterior part of knee joint cavity 28 days after arthroscopy.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: November 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Pain in the knee joint during more than a half day assessed by Visual Analog Pain Scale (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 liposuction

• 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 Cockcroft-Gault formula)

• Confirmed syphilis, HIV, hepatitis B or C infections

Dropout Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Liposuction

Other:
• SVF isolation
SVF will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution.
• Intraarticular administration of autologous SVF

Locations

Country	Name	City	State
Russian Federation	Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation	Moscow
Russian Federation	Orenburg City Clinical Hospital #4	Orenburg
Russian Federation	Orenburg Regional Clinical Donor Blood Center	Orenburg
Russian Federation	Orenburg Regional Clinical Hospital	Orenburg

Sponsors (2)

Lead Sponsor	Collaborator
Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati	Orenburg Regional Clinical Blood Donor Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAEs monitoring	Types, probability and severity of treatment emergent serious adverse events (SAEs)	4 weeks after treatment
Primary	SARs monitoring	Types, probability and severity of treatment emergent serious adverse reactions (SARs)	4 weeks after treatment
Secondary	Quality of life monitoring-1	Quality of life estimated by validated questionnaire - the Short Form (36) Health Survey (SF-36)	Follow up to completion (up to 24 weeks after treatment)
Secondary	Quality of life monitoring-2	Quality of life estimated by validated questionnaire - Knee Injury and Osteoarthritis Outcome Score (KOOS)	Follow up to completion (up to 24 weeks after treatment)
Secondary	Knee pain intensity monitoring	Knee pain intensity assessed by Visual Analog Pain Scale (no pain=0; maximum pain=100 mm)	Follow up to completion (up to 24 weeks after treatment)
Secondary	Changes in knee joint structure-1	Changes in knee joint structure assessed by 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)
Secondary	Changes in knee joint structure-2	Changes in knee joint structure assessed by X-ray (joint space width, bone contour, presence of osteophytes and sclerosis)	Follow up to completion (up to 24 weeks after treatment)
Secondary	Changes in knee joint structure-3	Changes in knee joint structure assessed by MRI (articular cartilage, osteophytes, bone marrow abnormality, meniscal integrity, synovial effusion/tissue, anterior and posterior cruciate ligaments, and medial and lateral collateral ligaments)	Follow up to completion (up to 24 weeks after treatment)
Secondary	Changes in knee function	Changes in knee function assessed by validated questionnaire: Knee Society Score (KSS)	Follow up to completion (up to 24 weeks after treatment)