Clinical trial NCT04326985: RCT Mesenchymal Stem Cells Versus Hyaluronic Acid in OA Knee):
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Osteoarthritis, Knee
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Controlled Trial
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Knee Society Score
timeFrame: One year
measure: Knee Society Function Score
timeFrame: One year
measure: Magnetic resonance image (MRI) and X-ray assessment
timeFrame: One year
Secondary outcomes:
measure: Health related quality of life score (HRQoL) - SF36
timeFrame: One year
measure: Western Ontario and McMaster Osteoarthritis Index (WOMAC)
timeFrame: One year
measure: Visual Analogic Scale (VAS) pain evaluation
timeFrame: One year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Orthopaedics & Traumatology
Study officials:
References: