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

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: Osteoarthritis, Knee
• Intervention / Treatment: Biological: Autologous Mesenchymal Stem Cells Treatment (MSCs); Drug: Hyaluronic acid (HA)

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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	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	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	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	Questionnaire Assessment	One year
Western Ontario and McMaster Osteoarthritis Index (WOMAC)	Questionnaire Assessment	One year
Visual Analogic Scale (VAS) pain evaluation	Questionnaire Assessment	One year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

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: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• 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