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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
International Stemcell Services Limited
ClinicalTrials.gov Identifier:
NCT01152125
First received: June 25, 2010
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Osteoarthritis
Other: Autologous bone marrow stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by International Stemcell Services Limited:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in the MRI knee with cartilage mapping and clinical improvement [ Time Frame: Baseline, 6 months, 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous bone marrow stem cells Other: Autologous bone marrow stem cells
Stem cells isolated from the patient's own bone marrow.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152125

Locations
India
St. Theresa's Hospital
Bengaluru, Karnataka, India, 560010
Sponsors and Collaborators
International Stemcell Services Limited
Investigators
Principal Investigator: Rudraprasad, M.S St. Theresa's Hospital
Study Director: Alphy Zachson, M.B.B.S International Stemcell Services Limited
  More Information

No publications provided

Responsible Party: Dr. SGA Rao, Chairman, International Stemcell Services Ltd.
ClinicalTrials.gov Identifier: NCT01152125     History of Changes
Other Study ID Numbers: ISSL-AuBM-OA
Study First Received: June 25, 2010
Last Updated: June 8, 2011
Health Authority: India: Indian Council of Medical Research

Keywords provided by International Stemcell Services Limited:
Osteoarthritis
stem cell implantation
bone marrow
autologous

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014