Osteoarthritis
Conditions
Keywords
Osteoarthritis, Bone marrow, Mesenchymal stem cells, Autologous, Mild osteoarthritis, 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.
Interventions
DRUGHyaluronic Acid
Intra-articular injection; 30mg/2ml; three-weekly injection regimen
Single intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in hyaluronic acid Orthovisc (3rd injection in a three-weekly injection regimen)
Sponsors
Cytopeutics Pte. Ltd.
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in cartilage thickness at 12 months by MRI | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Score | 1 month, 3 months, 6 months, 9 months, 12 months |
| IKDC Subjective Knee Evaluation Form (2000) | 1 month, 3 months, 6 months, 9 months, 12 months |
| Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray) | 12 months |
Countries
Malaysia
Contacts
Primary ContactYa Mohammad Hassan Shukur, MD
Outcome results
None listed