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Trial record 8 of 8 for:    Eremin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02827851
Recruitment Status : Enrolling by invitation
First Posted : July 11, 2016
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Orenburg Regional Clinical Blood Donor Center
Information provided by (Responsible Party):
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Liposuction Other: SVF isolation Other: Intraarticular administration of autologous SVF Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal Vascular Fraction of Cells for Treatment of Knee Articular Cartilage Dystrophy
Actual Study Start Date : May 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SVF injection
Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate stromal vascular fraction of cells (SVF). After SVF isolation autologous cells suspension will be injected intraarticularly into knee joint.
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.

Other: Intraarticular administration of autologous SVF



Primary Outcome Measures :
  1. SAEs monitoring [ Time Frame: 4 weeks after treatment ]
    Types, probability and severity of treatment emergent serious adverse events (SAEs)

  2. SARs monitoring [ Time Frame: 4 weeks after treatment ]
    Types, probability and severity of treatment emergent serious adverse reactions (SARs)


Secondary Outcome Measures :
  1. Quality of life monitoring-1 [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
    Quality of life estimated by validated questionnaire - the Short Form (36) Health Survey (SF-36)

  2. Quality of life monitoring-2 [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
    Quality of life estimated by validated questionnaire - Knee Injury and Osteoarthritis Outcome Score (KOOS)

  3. Knee pain intensity monitoring [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
    Knee pain intensity assessed by Visual Analog Pain Scale (no pain=0; maximum pain=100 mm)

  4. Changes in knee joint structure-1 [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
    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)

  5. Changes in knee joint structure-2 [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
    Changes in knee joint structure assessed by X-ray (joint space width, bone contour, presence of osteophytes and sclerosis)

  6. Changes in knee joint structure-3 [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
    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)

  7. 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)



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827851


Locations
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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, 121359
Orenburg City Clinical Hospital #4
Orenburg, Russian Federation, 460000
Orenburg Regional Clinical Donor Blood Center
Orenburg, Russian Federation, 460018
Orenburg Regional Clinical Hospital
Orenburg, Russian Federation, 460018
Sponsors and Collaborators
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Orenburg Regional Clinical Blood Donor Center
Investigators
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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: Rinat G Gilmutdinov, MD, PhD Orenburg Regional Clinical Donor Blood Center
Principal Investigator: Sergey I Gilfanov, MD, PhD, Prof Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Principal Investigator: Andrey A Averyanov, MD, PhD Orenburg Regional Clinical Hospital
Principal Investigator: Vadim A Kopylov, MD, PhD Orenburg City Clinical Hospital #4

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Responsible Party: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
ClinicalTrials.gov Identifier: NCT02827851     History of Changes
Other Study ID Numbers: RU-ССН-03-01-16
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation:
Damage of articular cartilage
Cartilage degeneration
Intraarticular injection
SVF
Stromal vascular fraction
Adipose-derived regenerative cells (ADRC)
Adipose tissue
Stem cells

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases