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

The Chinese University of Hong Kong

Status and phase: Completed; Early Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Drug: Hyaluronic acid (HA); Biological: Autologous Mesenchymal Stem Cells Treatment (MSCs)

Study type: Interventional

Funder types: Other

Identifiers

NCT04326985

OA MSC Study protocol v 1.4

Details and patient eligibility

About

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.

Full 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)

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Autologous Mesenchymal Stem Cells Treatment (MSCs)

Experimental group

Description:

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)

Treatment:

Biological: Autologous Mesenchymal Stem Cells Treatment (MSCs)

Hyaluronic acid (HA)

Active Comparator group

Description:

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)

Treatment:

Drug: Hyaluronic acid (HA)