Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Osteoarthritis
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Autologous bone marrow stem cells||
Other: Autologous bone marrow stem cells
Stem cells isolated from the patient's own bone marrow.
- 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 ]
- Changes in the MRI knee with cartilage mapping and clinical improvement [ Time Frame: Baseline, 6 months, 1 year ]
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 ClinicalTrials.gov identifier (NCT number): NCT01152125
|St. Theresa's Hospital|
|Bengaluru, Karnataka, India, 560010|
|Principal Investigator:||Rudraprasad, M.S||St. Theresa's Hospital|
|Study Director:||Alphy Zachson, M.B.B.S||International Stemcell Services Limited|