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

Osteoarthritis, Knee Clinical Trial

— MSC  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326985
• Other study ID #: OA MSC Study protocol v 1.4
• Status: Completed
• Phase: Early Phase 1
• Start date: January 31, 2015
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

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.)

Locations

Country	Name	City	State
Hong Kong	Department of Orthopaedics & Traumatology	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Magnetic resonance image (MRI) and X-ray assessment	Radiological assessment of the knee joint	One year
Secondary	Health related quality of life score (HRQoL) - SF36	Questionnaire Assessment	One year
Secondary	Western Ontario and McMaster Osteoarthritis Index (WOMAC)	Questionnaire Assessment	One year
Secondary	Visual Analogic Scale (VAS) pain evaluation	Questionnaire Assessment	One year