The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis

NCT03164083 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-03-18

No results posted yet for this study

Summary

Osteoarthritis of the knee is one of the most common causes of disability among elderly. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow Mesenchymal Stem Cells (MSC) and stromal Vascular Fraction (SVF) in patients with severe knee osteoarthritis

Conditions

Interventions

BIOLOGICAL

Mesenchymal stem cell

intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation

BIOLOGICAL

Placebo

Patients with knee joint osteoarthritis who underwent intra articular placebo injection

Sponsors & Collaborators

  • SCARM Institute, Tabriz, Iran

    lead OTHER_GOV

Principal Investigators

  • Mohammad Nouri, Ph.D · Head of SCARM Institute

  • Peyman Keyhanvar, MD, Ph.D · Deputy for translational medicine of SCARM institute

  • Seyed Kazem Shakouri, Physiatrist · Tabriz University of Medical Sciences

  • Neda keyhanvar, Ph.D · SCARM institute

  • Sepideh Bastani, MSc · SCARM institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-10
Primary Completion
2020-08-21
Completion
2020-12-05

Countries

  • Iran

Study Locations

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Entities

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 NCT03164083 on ClinicalTrials.gov