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Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01152125
Recruitment Status : Unknown
Verified June 2011 by International Stemcell Services Limited.
Recruitment status was:  Enrolling by invitation
First Posted : June 29, 2010
Last Update Posted : June 9, 2011
Information provided by:
International Stemcell Services Limited

Tracking Information
First Submitted Date  ICMJE June 25, 2010
First Posted Date  ICMJE June 29, 2010
Last Update Posted Date June 9, 2011
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2010)
  • Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score [ Time Frame: Baseline, 3 months, 6 months, 1 year ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2010)
Changes in the MRI knee with cartilage mapping and clinical improvement [ Time Frame: Baseline, 6 months, 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Osteoarthritis
Official Title  ICMJE Use of Autologous Bone Marrow Stem Cell Transplantation for Therapeutic Chondrogenesis in Moderate to Severe Osteoarthritis - ABM & LAM ST-OA Study
Brief Summary

Osteoarthritis is a leading cause of chronic disability in elderly and the risk of disability attributed to osteoarthritis is as great as or greater than due to any other medical condition in that age group. Several cross sectional studies have demonstrated an age related increase in the prevalence of osteoarthritis of knee(5). Results of survey are similar with most surgeons reporting 50+ years age group being commonest at initial presentation and that the incidence increases with advancing age. Interestingly some surgeons have noticed earlier occurrence of osteoarthritis in 40+ years age group and one has to be careful to screen for secondary causes in this younger age group patients.

While pain relief is the primary treatment goal of osteoarthritis medications, localized inflammation may also be relieved by using certain drugs. Managing osteoarthritis pain can involve medications, natural remedies, exercise, weight loss, joint protection, mobility aids, assisted devices and more.

Stem cell therapy, using cells extracted from the same patient or suitable alternative human sources, targets diseases which are either incurable or with no complete or effective treatment available in the traditional healthcare system. Since this therapy is based on the concept of regenerating damaged cells in the injured or disease-affected areas of the body, it is called regenerative medicine

Autologous stem cells provide an attractive option for osteoarthritis patients and their clinicians.

In our present study we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells in treatment of Osteoarthritis for therapeutic chondrogenesis through delivery of stem cells into the knee joint space in ten Indian patients.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE Other: Autologous bone marrow stem cells
Stem cells isolated from the patient's own bone marrow.
Study Arms  ICMJE Experimental: Autologous bone marrow stem cells
Intervention: Other: Autologous bone marrow stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 25, 2010)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2012
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Must be able to give voluntary written (patients may not be able to write) consent.
  2. Must be able to understand study information provided to him.
  3. Age 30 to 70, inclusive
  4. OA Kellgren and Lawrence classification 3 & 4
  5. No ligamentous laxity i.e. stable
  6. Ability to understand and willingness to sign consent form
  7. The participant is able to comply with and understand the required visit schedule and all required tests and procedures.

Exclusion Criteria:

  1. Serious pre-existing medical conditions like Diabetes Mellitus, Chronic Renal Failure, Rheumatoid Arthritis, Collagen vascular diseases and Autoimmune diseases
  2. Pregnant or lactating woman
  3. Inflammatory arthritis
  4. Oral steroid, methotrexate (immune suppressants)
  5. History of drug or alcohol abuse or chronic smoking
  6. Poor patient compliance
  7. Infectious disease test positive for HIV 1&2, HbsAg, HCV and VDRL.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01152125
Other Study ID Numbers  ICMJE ISSL-AuBM-OA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. SGA Rao, Chairman, International Stemcell Services Ltd.
Study Sponsor  ICMJE International Stemcell Services Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rudraprasad, M.S St. Theresa's Hospital
Study Director: Alphy Zachson, M.B.B.S International Stemcell Services Limited
PRS Account International Stemcell Services Limited
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP