NCT01459640

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

3 years

First QC Date

October 24, 2011

Last Update Submit

October 24, 2011

Conditions

Osteoarthritis

Keywords

OsteoarthritisBone marrowMesenchymal stem cellsAutologousMild osteoarthritisModerate osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in cartilage thickness at 12 months by MRI

    12 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

Hyaluronic acid

ACTIVE COMPARATOR
Drug: Hyaluronic Acid

Bone marrow mesenchymal stem cells

EXPERIMENTAL

Autologous bone marrow-derived mesenchymal stem cells

Biological: Autologous bone marrow-derived mesenchymal stem cells

Interventions

Hyaluronic AcidDRUG

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

Also known as: Orthovisc
Hyaluronic acid
Autologous bone marrow-derived mesenchymal stem cellsBIOLOGICAL

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

Bone marrow mesenchymal stem cells

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKM Medical Centre

Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Hyaluronic Acidorthovisc

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Ya Mohammad Hassan Shukur, MD

    UKM Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya Mohammad Hassan Shukur, MD

CONTACT

mhassan@ppukm.ukm.my

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant Orthopedic Surgeon

Study Record Dates

First Submitted

October 24, 2011

First Posted

October 25, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 25, 2011

Record last verified: 2011-10

Locations

MY(1)