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Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis

Primary Purpose

Osteoarthritis

Status

Unknown status

Phase

Phase 2

Locations

Malaysia

Study Type

Interventional

Intervention

Hyaluronic Acid

Autologous bone marrow-derived mesenchymal stem cells

About this trial

This is an interventional prevention trial for Osteoarthritis focused on measuring Osteoarthritis, Bone marrow, Mesenchymal stem cells, Autologous, Mild osteoarthritis, Moderate osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed with mild to moderate osteoarthritis based on Kellgren-Lawrence radiographic classification
Has a history of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage

Exclusion Criteria:

Has systemic bone or cartilage disorders
Has significant vascular impairment proximal to implant site
Has substantial joint destabilization including extensive osteophyte formation
Has substantial surface erosion of the weight-bearing articular cartilage
Evidence of infection or fractures in or around the joint
Contraindication to bone marrow aspiration
Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
Any past history of neoplasia and primary hematological disease
Renal impairment indicated by serum creatinine greater than 200mM
Liver impairment indicated by serum aspartate transaminase and serum alanine transaminase greater than 120 IU
Any other co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy

Sites / Locations

UKM Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hyaluronic acid

Bone marrow mesenchymal stem cells

Arm Description

Autologous bone marrow-derived mesenchymal stem cells

Outcomes

Primary Outcome Measures

Change from baseline in cartilage thickness at 12 months by MRI

Secondary Outcome Measures

Visual Analog Score

IKDC Subjective Knee Evaluation Form (2000)

Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)

Full Information

NCT ID

NCT01459640

First Posted

October 24, 2011

Last Updated

October 24, 2011

Sponsor

National University of Malaysia

Collaborators

Cytopeutics Pte. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01459640

Brief Title

Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis

Official Title

Phase 2 Study Assessing the Efficacy of Intra-Articular Autologous Mesenchymal Stem Cells in Patients With Mild to Moderate Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Malaysia

Collaborators

Cytopeutics Pte. Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Osteoarthritis is a progressively degenerative disease resulting in increasing pain, impairment and ultimately disability. While the available treatments seek to ameliorate pain or improve mobility, these treatments rarely modify the course of the disease, but rather attend to its consequences. For early stage osteoarthritis, treatment is largely limited to addressing the symptoms of inflammation with non-steroidal anti-inflammatory drugs (NSAIDs). These drugs do not stop the progression of the condition or regenerates damaged cartilage. This is a randomized and open labelled study aimed to determine the efficacy of intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in patients with mild to moderate osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Osteoarthritis, Bone marrow, Mesenchymal stem cells, Autologous, Mild osteoarthritis, Moderate osteoarthritis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hyaluronic acid

Arm Type

Active Comparator

Arm Title

Bone marrow mesenchymal stem cells

Arm Type

Experimental

Arm Description

Autologous bone marrow-derived mesenchymal stem cells

Intervention Type

Drug

Intervention Name(s)

Hyaluronic Acid

Other Intervention Name(s)

Orthovisc

Intervention Description

Intra-articular injection; 30mg/2ml; three-weekly injection regimen

Intervention Type

Biological

Intervention Name(s)

Autologous bone marrow-derived mesenchymal stem cells

Intervention Description

Single intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in hyaluronic acid "Orthovisc" (3rd injection in a three-weekly injection regimen)

Primary Outcome Measure Information:

Title

Change from baseline in cartilage thickness at 12 months by MRI

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Visual Analog Score

Time Frame

1 month, 3 months, 6 months, 9 months, 12 months

Title

IKDC Subjective Knee Evaluation Form (2000)

Time Frame

1 month, 3 months, 6 months, 9 months, 12 months

Title

Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosed with mild to moderate osteoarthritis based on Kellgren-Lawrence radiographic classification Has a history of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage Exclusion Criteria: Has systemic bone or cartilage disorders Has significant vascular impairment proximal to implant site Has substantial joint destabilization including extensive osteophyte formation Has substantial surface erosion of the weight-bearing articular cartilage Evidence of infection or fractures in or around the joint Contraindication to bone marrow aspiration Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV Any past history of neoplasia and primary hematological disease Renal impairment indicated by serum creatinine greater than 200mM Liver impairment indicated by serum aspartate transaminase and serum alanine transaminase greater than 120 IU Any other co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ya Mohammad Hassan Shukur, MD

mhassan@ppukm.ukm.my

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ya Mohammad Hassan Shukur, MD

Organizational Affiliation

UKM Medical Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

UKM Medical Centre

City

Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ya Mohammad Hassan Shukur, MD

First Name & Middle Initial & Last Name & Degree

Ya Mohammad Hassan Shukur, MD

First Name & Middle Initial & Last Name & Degree

Johan Ahmad, MD

12. IPD Sharing Statement

Learn more about this trial

Intra-Articular Autologous Bone Marrow Mesenchymal Stem Cells Transplantation to Treat Mild to Moderate Osteoarthritis

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