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Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment

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ClinicalTrials.gov Identifier: NCT02967874
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Alexander A Ostanin, Russian Academy of Medical Sciences

Brief Summary:

Adipose-derived stromal vascular fraction cells (SVFs) include regenerative cell populations (hematopoietic cells, pericytes, endothelial cells and progenitors, stromal/stem cells) and thus are potentially important as new therapeutic tools for the repair and regeneration of acute and chronically damaged tissues.

The general objective of this study is to evaluate safety and clinical efficacy of a single intra-articular injection of freshly isolated auto-SVFs for the treatment of patients with knee osteoarthritis (OA). This study uses autologous adipose-derived SVFs, as therapeutic agent and intra-articular administration, as a mode of delivery. Expected clinical effects: a treatment reduces pain, increases function and reduces stiffness in the knees of osteoarthritic subjects.


Condition or disease Intervention/treatment Phase
Osteoarthritis Joint Disease Osteoarthritis,Knee Arthritis, Degenerative Osteoarthrosis Osteoarthrosis Deformans Procedure: Intra-articular auto-SVFs injection Drug: Hyaluronic Acid Phase 1 Phase 2

Detailed Description:

Subcutaneous human adipose tissue is an abundant and accessible cell source for applications in tissue engineering and regenerative medicine. Methods to extract stromal/stem cells from the waste products of abdominoplasty, cosmetic surgery, and liposuction are now well developed. Routinely, the adipose tissue is digested with collagenase or related enzymes to release a heterogeneous population of SVF cells. The SVF cells can be used directly or can be cultured in plastic ware to select and expand an adherent population known as adipose-derived stromal/stem cells.

Osteoarthritis is the most common joint disease that affects at least 20% of the world population. The disease usually begins at the age of 40 years. Radiographic signs of osteoarthritis are diagnosed in 50% of people aged 55 years and 80% - over 75 years. OA can cause severe pain and stiffness in the affected joints, thus reducing joint's functionality. Therefore a treatment that would reduce pain/stiffness and increase joint function would be of benefit to many people. Safety and feasibility of SVFs in OA patients have been shown in few clinical studies.

This trial is a prospective, controlled, non-randomized, non-blinded, interventional study to determine safety and efficacy of a single injection of freshly isolated autologous SVFs into the knees of osteoarthritic patients (Grade II-III). In experimental group the participants (n=16) will undergo a standard liposuction to harvest adipose tissue, then the adipose tissue will be processed to obtain the SVFs and patients will receive a single intra-articular injection of auto-SVFs into affected knees under the ultrasound navigation. In parallel control group the participants (n=11) will receive a single intra-articular injection of hyaluronic acid (Synocrom Forte 2%) under the ultrasound navigation. The safety of auto-SVFs injection will be evaluated by assessment of the frequency and nature of adverse events occurring during or immediately after the procedure, and up to the one year following treatment. Patients will be monitored during 1, 3, 6 and 12- month's visits.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety/Efficacy of Intra-articularly Administrated Autologous Adipose -Derived Stromal Vascular Fraction Cells in Treatment of Knee Osteoarthritis
Study Start Date : March 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Intra-articular auto-SVFs injection

The participants will undergo a standard liposuction to harvest adipose tissue. The adipose tissue will then be processed to obtain the SVFs.

This group of subjects (n=16) will receive a single injection of auto-SVFs into affected knees (3.0 mL cell suspension/joint).

Procedure: Intra-articular auto-SVFs injection
Liposuction under local anesthesia followed by single intra-articular injection of auto-SVFs under the ultrasound navigation

Active Comparator: Intra-articular Hyaluronic Acid
This group of subjects (n=11) will receive a single injection of Synocrom Forte 2% into affected knees (1.0 mL/joint).
Drug: Hyaluronic Acid
Single intra-articular injection of Synocrom Forte 2% under the ultrasound navigation
Other Name: Synocrom Forte




Primary Outcome Measures :
  1. The number of patients with adverse events [ Time Frame: up to 12 months after treatment ]
    The safety of intra-articular injection of auto-SVFs will be evaluated by assessment of the frequency and nature of adverse events during or immediately after the procedure, and up to the 12-months following treatment


Secondary Outcome Measures :
  1. Change in pain score on the Visual Analogue Scale (VAS) at all follow-up visits [ Time Frame: Baseline, 1, 3, 6 and 12 months after treatment ]
    The severity of joint pain, which is determined by the patient from 0 (no pain) to 10 points (unbearable pain), will be evaluated.

  2. Change in Knee injury and Osteoarthritis Outcome Score (KOOS) at all follow-up visits [ Time Frame: Baseline, 1, 3, 6 and 12 months after treatment ]
    KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  3. Change in Ultrasonography of the knee joints [ Time Frame: Baseline, 3, 6 and 12 months after treatment ]


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 40 to 85 Years (Adult, Senior)
  • Grade II or Grade III osteoarthritis of the knee joints using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray and physician review, and/or MRI
  • Patients must have continued pain in the knee despite conservative therapies for at least 3 months
  • Patients must be able to tolerate all study procedures
  • Patients must be willing to voluntarily give written Informed Consent to participate in the study before any procedures are performed
  • Patients must be willing to be available for all baseline, treatment and follow-up examinations required by protocol

Exclusion Criteria:

  • Subjects with a BMI > 35
  • Subjects who have had an injection in either knee in the prior 4 weeks, including corticosteroids, drugs of hyaluronic acid or platelet rich plasma (PRP).
  • Subjects who have had surgery of either knee within 6 months prior to the screening visit
  • Subjects those are allergic to drugs for local anesthesia
  • Psychiatric disorders
  • Hepatic or renal dysfunctions
  • Hemodynamic or respiratory instability
  • HIV or uncontrolled bacterial, fungal, or viral infections
  • Autoimmune diseases (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, etc)
  • Pregnancy
  • Malignancy
  • Participation in other clinical trials

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): NCT02967874


Locations
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Russian Federation
Institute of Fundamental and Clinical Immunology
Novosibirsk, Russian Federation, 630099
Sponsors and Collaborators
Russian Academy of Medical Sciences
Investigators
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Study Chair: Elena R Chernykh, MD, PhD Institute of Fundamental and Clinical Immunology
Principal Investigator: Alexander A Ostanin, MD, PhD Institute of Fundamental and Clinical Immunology

Publications:
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Responsible Party: Alexander A Ostanin, Head of Clinical Department, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02967874     History of Changes
Other Study ID Numbers: IFCI-10/11/2015
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Keywords provided by Alexander A Ostanin, Russian Academy of Medical Sciences:
Adipose -Derived Stromal Vascular Fraction Cells
Knee Osteoarthritis
Intra-articular Administration
Liposuction
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents