NCT04326985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2015

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

4 years

First QC Date

March 27, 2020

Last Update Submit

May 14, 2020

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (3)

  • Knee Society Score

    Clinical Questionnaire Assessment Tool. Score 80-100 = Excellent, Score 70-79 = Good, Score 60-69 = Fair, Score below 60 = Poor

    One year

  • Knee Society Function Score

    Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome.

    One year

  • Magnetic resonance image (MRI) and X-ray assessment

    Radiological assessment of the knee joint

    One year

Secondary Outcomes (3)

  • Health related quality of life score (HRQoL) - SF36

    One year

  • Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    One year

  • Visual Analogic Scale (VAS) pain evaluation

    One year

Study Arms (2)

Autologous Mesenchymal Stem Cells Treatment (MSCs)

EXPERIMENTAL

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)

Biological: Autologous Mesenchymal Stem Cells Treatment (MSCs)

Hyaluronic acid (HA)

ACTIVE COMPARATOR

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)

Drug: Hyaluronic acid (HA)

Interventions

Autologous Mesenchymal Stem Cells Treatment (MSCs)BIOLOGICAL

The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.

Autologous Mesenchymal Stem Cells Treatment (MSCs)
Hyaluronic acid (HA)DRUG

The HA group patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.)

Hyaluronic acid (HA)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics & Traumatology

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professional Consultant

Study Record Dates

First Submitted

March 27, 2020

First Posted

March 30, 2020

Study Start

January 31, 2015

Primary Completion

January 30, 2019

Study Completion

February 28, 2019

Last Updated

May 18, 2020

Record last verified: 2020-05

Locations

HK(1)