RCT Mesenchymal Stem Cells Versus Hyaluronic Acid in OA Knee): (MSC)

May 14, 2020 updated by: Dr. Ho Ki Wai, Chinese University of Hong Kong

A Randomized Control Clinical Trial to Evaluate the Efficacy of Intra-articular Injections of Mesenchymal Stem Cells Versus Hyaluronic Acid in Patients Affected by Osteoarthritis of the Knee

The purpose of this study is to evaluate the therapeutic effect of adult autologous mesenchymal stem cells (abbreviated as MSCs) in patients with osteoarthritic knee and compare to intra articular injection of Synvisc-One.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Participants:

This study will involve patients affected by osteoarthritis who comply with the inclusion and exclusion criteria. 30 patients, between the age of 18 and <65, will be enrolled in the study and randomized into three groups to receive either an injection of MSCs, hyaluronic acid (HA) or no injection.

Type of Study: This is a randomized control study.

Treatment method: Each patient will randomly be assigned to one of the following treatment groups:

Group A) Mesenchymal stem cells (MSCs) Group B) Hyaluronic acid (HA) Group C) No injection

Treatment:

Group A) Autologous Mesenchymal Stem Cells Treatment (MSCs) The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.

The treatment will be carried out after the patient has received a blood test and clinically evaluated at T0.

T0: Beginning of the study, blood test and bone marrow aspiration. T30: Intra-articular injection of MSCs T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)

Group B) Hyaluronic acid (HA) The patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) The hyaluronic acid will be purchased for the patient from the manufacturer or from the pharmacy of the hospital.

The intra-articular injection will be carried out after the patient has received a clinical evaluation at T0.

T0: Beginning of the study T30: Intra-articular injection of Synvisc-One (HA) T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Orthopaedics & Traumatology

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects aged between 18 and < 65
  • Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 and 3
  • Patients on a pain level equal to or higher than 5 on a VAS scale of 10

Exclusion Criteria:

  • Previous cases of alcoholism or drug abuse
  • Pregnancy and breast-feeding
  • Serious pathologies such as carcinoma or autoimmune disease
  • Hypersensitivity toward Hyaluorinc Acid
  • Undergoing steroid-based systemic therapy or interrupted since less than 1 month
  • Significant hematologic diseases
  • Mechanical instability, ligamentous laxity/deficiency or gross deformity

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Mesenchymal Stem Cells Treatment (MSCs)

The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.

The treatment will be carried out after the patient has received a blood test and clinically evaluated at T0.

T0: Beginning of the study, blood test and bone marrow aspiration. T30: Intra-articular injection of MSCs T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)
Biological: Autologous Mesenchymal Stem Cells Treatment (MSCs)
The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.
Active Comparator: Hyaluronic acid (HA)

The patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) The hyaluronic acid will be purchased for the patient from the manufacturer or from the pharmacy of the hospital.The intra-articular injection will be carried out after the patient has received a clinical evaluation at T0.

T0: Beginning of the study T30: Intra-articular injection of Synvisc-One (HA) T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)
Drug: Hyaluronic acid (HA)
The HA group patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Society Score
Time Frame: One year
Clinical Questionnaire Assessment Tool. Score 80-100 = Excellent, Score 70-79 = Good, Score 60-69 = Fair, Score below 60 = Poor
One year
Knee Society Function Score
Time Frame: One year
Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome.
One year
Magnetic resonance image (MRI) and X-ray assessment
Time Frame: One year
Radiological assessment of the knee joint
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life score (HRQoL) - SF36
Time Frame: One year
Questionnaire Assessment
One year
Western Ontario and McMaster Osteoarthritis Index (WOMAC)
Time Frame: One year
Questionnaire Assessment
One year
Visual Analogic Scale (VAS) pain evaluation
Time Frame: One year
Questionnaire Assessment
One year

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

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 (Actual)

January 31, 2015

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OA MSC Study protocol v 1.4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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