Title

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

    Phase 2
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    50
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.
Study Started
Mar 31
2011
Primary Completion
Mar 31
2014
Anticipated
Study Completion
Mar 31
2014
Anticipated
Last Update
Oct 25
2011
Estimate

Drug Hyaluronic Acid

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

  • Other names: Orthovisc

Biological 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)

Hyaluronic acid Active Comparator

Bone marrow mesenchymal stem cells Experimental

Autologous bone marrow-derived mesenchymal stem cells

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
No Results Posted