Clinical trial NCT01459640: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Bone marrow
Mesenchymal stem cells
Autologous
Mild osteoarthritis
Moderate osteoarthritis
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Cytopeutics Pte. Ltd.
First posted: 2011-10-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change from baseline in cartilage thickness at 12 months by MRI
timeFrame: 12 months
Secondary outcomes:
measure: Visual Analog Score
timeFrame: 1 month, 3 months, 6 months, 9 months, 12 months
measure: IKDC Subjective Knee Evaluation Form (2000)
timeFrame: 1 month, 3 months, 6 months, 9 months, 12 months
measure: Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray)
timeFrame: 12 months
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: UKM Medical Centre
Study officials:
affiliation: UKM Medical Centre
name: Ya Mohammad Hassan Shukur, MD
role: PRINCIPAL_INVESTIGATOR
References: