Clinical trial NCT01152125: Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Osteoarthritis
Official title: Use of Autologous Bone Marrow Stem Cell Transplantation for Therapeutic Chondrogenesis in Moderate to Severe Osteoarthritis - ABM & LAM ST-OA Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Keywords: Osteoarthritis
stem cell implantation
bone marrow
autologous
Lead sponsor: International Stemcell Services Limited
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
timeFrame: Baseline, 3 months, 6 months, 1 year
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 1 year
Secondary outcomes:
measure: Changes in the MRI knee with cartilage mapping and clinical improvement
timeFrame: Baseline, 6 months, 1 year
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: St. Theresa's Hospital
state: Karnataka
Study officials:
affiliation: St. Theresa's Hospital
name: Rudraprasad, M.S
role: PRINCIPAL_INVESTIGATOR
affiliation: International Stemcell Services Limited
name: Alphy Zachson, M.B.B.S
role: STUDY_DIRECTOR
References: