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

NCT01152125 | Unknown Phase 1 DMC

• 1 other identifier: ISSL-AuBM-OA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; stem cell implantation; bone marrow; autologous

Outcome Measures

Primary Outcomes (2)

• Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score

  Baseline, 3 months, 6 months, 1 year

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  1 year

Secondary Outcomes (1)

• Changes in the MRI knee with cartilage mapping and clinical improvement

  Baseline, 6 months, 1 year

Study Arms (1)

Autologous bone marrow stem cells

EXPERIMENTAL

Other: Autologous bone marrow stem cells

Interventions

Autologous bone marrow stem cells OTHER

Stem cells isolated from the patient's own bone marrow.

Autologous bone marrow stem cells

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Serious pre-existing medical conditions like Diabetes Mellitus, Chronic Renal Failure, Rheumatoid Arthritis, Collagen vascular diseases and Autoimmune diseases
• Pregnant or lactating woman
• Inflammatory arthritis
• Oral steroid, methotrexate (immune suppressants)
• History of drug or alcohol abuse or chronic smoking
• Poor patient compliance
• Infectious disease test positive for HIV 1\&2, HbsAg, HCV and VDRL.

Sponsors & Collaborators

• International Stemcell Services Limited: lead

Study Sites (1)

St. Theresa's Hospital

Bengaluru, Karnataka, 560010, India

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rudraprasad, M.S

  St. Theresa's Hospital

  PRINCIPAL INVESTIGATOR

• Alphy Zachson, M.B.B.S

  International Stemcell Services Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: January 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

IN (1)