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Completed

NCT Number: NCT04326985

RCT Mesenchymal Stem Cells Versus Hyaluronic Acid in OA 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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Orthopaedics & Traumatology

Hong Kong

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Mesenchymal Stem Cells Treatment (MSCs)

Biological

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

Hyaluronic Acid (HA)

Drug

The HA group patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.)

Primary outcomes

  1. 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

  2. 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.

  3. Magnetic resonance image (MRI) and X-ray assessment

    Time frame: One year

    Radiological assessment of the knee joint

Secondary outcomes

  1. Health related quality of life score (HRQoL) - SF36

    Time frame: One year

    Questionnaire Assessment

  2. Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    Time frame: One year

    Questionnaire Assessment

  3. Visual Analogic Scale (VAS) pain evaluation

    Time frame: One year

    Questionnaire Assessment

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: MSC

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2020
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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