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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

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Other: Autologous bone marrow stem cells Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Autologous Bone Marrow Stem Cell Transplantation for Therapeutic Chondrogenesis in Moderate to Severe Osteoarthritis - ABM & LAM ST-OA Study
Study Start Date : January 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Autologous bone marrow stem cells Other: Autologous bone marrow stem cells
Stem cells isolated from the patient's own bone marrow.

Primary Outcome Measures :
  1. 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 ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Changes in the MRI knee with cartilage mapping and clinical improvement [ Time Frame: Baseline, 6 months, 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01152125

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St. Theresa's Hospital
Bengaluru, Karnataka, India, 560010
Sponsors and Collaborators
International Stemcell Services Limited
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Principal Investigator: Rudraprasad, M.S St. Theresa's Hospital
Study Director: Alphy Zachson, M.B.B.S International Stemcell Services Limited
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Responsible Party: Dr. SGA Rao, Chairman, International Stemcell Services Ltd. Identifier: NCT01152125    
Other Study ID Numbers: ISSL-AuBM-OA
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011
Keywords provided by International Stemcell Services Limited:
stem cell implantation
bone marrow
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases