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

NCT ID: NCT01459640

Last Updated: 2011-10-25

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hyaluronic acid

Group Type ACTIVE_COMPARATOR

Hyaluronic Acid

Intervention Type DRUG

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

Bone marrow mesenchymal stem cells

Autologous bone marrow-derived mesenchymal stem cells

Group Type EXPERIMENTAL

Autologous bone marrow-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

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

Interventions

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Hyaluronic Acid

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

Intervention Type DRUG

Autologous bone marrow-derived mesenchymal stem cells

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Orthovisc

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cytopeutics Pte. Ltd.

INDUSTRY

Sponsor Role collaborator

National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Dr Ya Mohammad Hassan Shukur

Senior Consultant Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ya Mohammad Hassan Shukur, MD

Role: PRINCIPAL_INVESTIGATOR

UKM Medical Centre

Locations

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UKM Medical Centre

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Ya Mohammad Hassan Shukur, MD

Role: CONTACT

[email protected]

Facility Contacts

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Ya Mohammad Hassan Shukur, MD

Role: primary

Other Identifiers

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FF-114-2011

Identifier Type: -

Identifier Source: org_study_id