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

Osteoarthritis Clinical Trial

Official title:

Use of Autologous Bone Marrow Stem Cell Transplantation for Therapeutic Chondrogenesis in Moderate to Severe Osteoarthritis - ABM & LAM ST-OA Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01152125
• Other study ID #: ISSL-AuBM-OA
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: June 25, 2010
• Last updated: June 8, 2011
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: June 2011
• Source: International Stemcell Services Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: January 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Autologous bone marrow stem cells
Stem cells isolated from the patient's own bone marrow.

Locations

Country	Name	City	State
India	St. Theresa's Hospital	Bengaluru	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
International Stemcell Services Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score		Baseline, 3 months, 6 months, 1 year	No
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		1 year	Yes
Secondary	Changes in the MRI knee with cartilage mapping and clinical improvement		Baseline, 6 months, 1 year	No