RCT Mesenchymal Stem Cells Versus Hyaluronic Acid in OA Knee):
- Conditions
- Osteoarthritis, Knee
- Interventions
- Biological: Autologous Mesenchymal Stem Cells Treatment (MSCs)Drug: Hyaluronic acid (HA)
- Registration Number
- NCT04326985
- Lead Sponsor
- Chinese University of Hong Kong
- Brief 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.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Autologous Mesenchymal Stem Cells Treatment (MSCs) 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) Hyaluronic acid (HA) 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)
- Primary Outcome Measures
Name Time Method Knee Society Score One year Clinical Questionnaire Assessment Tool. Score 80-100 = Excellent, Score 70-79 = Good, Score 60-69 = Fair, Score below 60 = Poor
Knee Society Function Score One year Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome.
Magnetic resonance image (MRI) and X-ray assessment One year Radiological assessment of the knee joint
- Secondary Outcome Measures
Name Time Method Visual Analogic Scale (VAS) pain evaluation One year Questionnaire Assessment
Western Ontario and McMaster Osteoarthritis Index (WOMAC) One year Questionnaire Assessment
Health related quality of life score (HRQoL) - SF36 One year Questionnaire Assessment
Trial Locations
- Locations (1)
Department of Orthopaedics & Traumatology
ðŸ‡ðŸ‡°Hong Kong, Hong Kong