Osteoarthritis, Knee
Conditions
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)
Interventions
BIOLOGICALAutologous 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.
DRUGHyaluronic acid (HA)
The HA group patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.)
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life score (HRQoL) - SF36 | One year | Questionnaire Assessment |
| Western Ontario and McMaster Osteoarthritis Index (WOMAC) | One year | Questionnaire Assessment |
| Visual Analogic Scale (VAS) pain evaluation | One year | Questionnaire Assessment |
Countries
Hong Kong
Outcome results
None listed