RCT Mesenchymal Stem Cells Versus Hyaluronic Acid in OA Knee):
NCT ID: NCT04326985
Last Updated: 2020-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
20 participants
INTERVENTIONAL
2015-01-31
2019-02-28
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
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.
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)
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.)
Interventions
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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.
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.)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Dr. Ho Ki Wai
Clinical Professional Consultant
Locations
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Department of Orthopaedics & Traumatology
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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OA MSC Study protocol v 1.4
Identifier Type: -
Identifier Source: org_study_id
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