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Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment

NCT02967874 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-09-13

No results posted yet for this study

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

Interventions

PROCEDURE

Intra-articular auto-SVFs injection

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

DRUG

Hyaluronic Acid

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

Sponsors & Collaborators

  • Russian Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Elena R Chernykh, MD, PhD · Institute of Fundamental and Clinical Immunology

  • Alexander A Ostanin, MD, PhD · Institute of Fundamental and Clinical Immunology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-06-30
Completion
2019-09-30

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02967874 on ClinicalTrials.gov