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

March 16, 2020 updated by: SCARM Institute, Tabriz, Iran

Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells and Stromal Vascular Fraction Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is single center, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. All subjects will undergo bone marrow aspiration. Mesenchymal Stem Cells will be isolated from bone marrow and stromal Vascular Fraction fram lipoaspirate, cultured and transplanted back to the knee joint. Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo will be administered in this group 6 months after the first injection. Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed before and 6 months after the first injection by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Osteoarthritis diagnosed by MRI

Exclusion Criteria:

  • Pregnancy or lactating
  • Positive tests for HIV, Hepatitis C virus (HCV), Hepatitis C virus (HBV)
  • Active neurologic disorder
  • End organ damage
  • Uncontrolled endocrine disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mesenchymal stem cell
Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection
Biological: Mesenchymal stem cell
intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation
Experimental: placebo
The patients who are in control group and underwent placebo injection
Biological: Placebo
Patients with knee joint osteoarthritis who underwent intra articular placebo injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical function improvement
Time Frame: 2 weeks
Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection
2 weeks
Change in pain density
Time Frame: 2 weeks
Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint swelling
Time Frame: 3 months
Evaluation the joint swelling by physical examination after intra articular cell injection
3 months
Joint erythema
Time Frame: 3 months
Evaluation the joint erythema by physical examination after cell injection
3 months
Deterioration of joint function
Time Frame: 3 months
Evaluation the deterioration of joint function by physical examination after intra articular cell injection
3 months
Allergic reactions
Time Frame: 3 months
Evaluation the allergic reactions like skin rash,skin erythema, dyspnea by physical examination after cell injection
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCARM Institute, Tabriz, Iran

Investigators

  • Principal Investigator: Seyed Kazem Shakouri, Physiatrist, Tabriz University of Medical Sciences
  • Principal Investigator: Neda keyhanvar, Ph.D, SCARM Institute
  • Principal Investigator: Sepideh Bastani, MSc, SCARM Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 10, 2019

Primary Completion (Anticipated)

August 21, 2020

Study Completion (Anticipated)

December 5, 2020

Study Registration Dates

First Submitted

May 21, 2017

First Submitted That Met QC Criteria

May 21, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCARM-Osteoarthritis-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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