Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment

NCT02967874 | Completed Phase 1

• 1 other identifier: IFCI-10/11/2015
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Joint Disease; Osteoarthritis,Knee; Arthritis, Degenerative; Osteoarthrosis; Osteoarthrosis Deformans

Keywords

Adipose -Derived Stromal Vascular Fraction Cells; Knee Osteoarthritis; Intra-articular Administration; Liposuction

Outcome Measures

Primary Outcomes (1)

• The number of patients with adverse events

  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

  up to 12 months after treatment

Secondary Outcomes (3)

• Change in pain score on the Visual Analogue Scale (VAS) at all follow-up visits

  Baseline, 1, 3, 6 and 12 months after treatment

• Change in Knee injury and Osteoarthritis Outcome Score (KOOS) at all follow-up visits

  Baseline, 1, 3, 6 and 12 months after treatment

• Change in Ultrasonography of the knee joints

  Baseline, 3, 6 and 12 months after treatment

Study Arms (2)

Intra-articular auto-SVFs injection

EXPERIMENTAL

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

Intra-articular Hyaluronic Acid

ACTIVE COMPARATOR

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

Interventions

Intra-articular auto-SVFs injection PROCEDURE

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

Intra-articular auto-SVFs injection

Hyaluronic Acid DRUG

Single intra-articular injection of Synocrom Forte 2% under the ultrasound navigation

Also known as: Synocrom Forte

Intra-articular Hyaluronic Acid

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead

Study Sites (1)

Institute of Fundamental and Clinical Immunology

Novosibirsk, 630099, Russia

Location

Related Publications (2)

• Michalek J, Moster R, Lukac L, Proefrock K, Petrasovic M, Rybar J, Capkova M, Chaloupka A, Darinskas A, Michalek J Sr, Kristek J, Travnik J, Jabandziev P, Cibulka M, Holek M, Jurik M, Skopalik J, Kristkova Z, Dudasova Z. WITHDRAWN: Autologous adipose tissue-derived stromal vascular fraction cells application in patients with osteoarthritis. Cell Transplant. 2015 Jan 20. doi: 10.3727/096368915X686760. Online ahead of print.

  PMID: 25706817 BACKGROUND

• Garza GR, Palomera T, Dumanian GA, Dos-Anjos S. Use of autologous adipose-derived stromal vascular fraction to treat osteoarthritis of the knee: a feasibility and safety study. J Regen Med. 4(1), 2015 doi:10.4172/2325-9620.1000119

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases; Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Elena R Chernykh, MD, PhD

  Institute of Fundamental and Clinical Immunology

  STUDY CHAIR

• Alexander A Ostanin, MD, PhD

  Institute of Fundamental and Clinical Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Department

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

RU (1)