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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Osteoarthritis
Intervention	Drug: Hyaluronic Acid Biological: Autologous bone marrow-derived mesenchymal stem cells
Phase	Phase 2
Sponsor	National University of Malaysia
Responsible Party	National University of Malaysia
ClinicalTrials.gov Identifier	NCT01459640
First Received	October 24, 2011
Last Updated	October 24, 2011
Last verified	October 2011

Tracking Information[ + expand ][ + ]

First Received Date	October 24, 2011
Last Updated Date	October 24, 2011
Start Date	March 2011
Estimated Primary Completion Date	March 2014
Current Primary Outcome Measures	Change from baseline in cartilage thickness at 12 months by MRI [Time Frame: 12 months] [Designated as safety issue: No]
Current Secondary Outcome Measures	Visual Analog Score [Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months] [Designated as safety issue: Yes] IKDC Subjective Knee Evaluation Form (2000) [Time Frame: 1 month, 3 months, 6 months, 9 months, 12 months] [Designated as safety issue: Yes] Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray) [Time Frame: 12 months] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Condition	Osteoarthritis
Intervention	Drug: Hyaluronic Acid Intra-articular injection; 30mg/2ml; three-weekly injection regimen Other Names: OrthoviscBiological: 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)
Study Arm (s)	Active Comparator: Hyaluronic acid Experimental: Bone marrow mesenchymal stem cells Autologous bone marrow-derived mesenchymal stem cells

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	50
Estimated Completion Date	March 2014
Estimated Primary Completion Date	March 2014
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Ya Mohammad Hassan Shukur, MD mhassan@ppukm.ukm.my
Location Countries	Malaysia

Administrative Information[ + expand ][ + ]

NCT Number	NCT01459640
Other Study ID Numbers	FF-114-2011
Has Data Monitoring Committee	No
Information Provided By	National University of Malaysia
Study Sponsor	National University of Malaysia
Collaborators	Cytopeutics Pte. Ltd.
Investigators	Principal Investigator: Ya Mohammad Hassan Shukur, MD UKM Medical Centre
Verification Date	October 2011

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