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Status unknownNCT01152125Updated Jun 9, 2011

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

A Phase 1/2 interventional study of Autologous bone marrow stem cells in Osteoarthritis, sponsored by International Stemcell Services Limited. Status unknown at 1 site in India. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-06-09.

Sponsored by International Stemcell Services Limited · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis

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Keywords

  • Osteoarthritis
  • stem cell implantation
  • bone marrow
  • autologous
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 10 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

International Stemcell Services Limited is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Autologous bone marrow stem cells

    Other: Autologous bone marrow stem cells

Interventions

  • OtherAutologous bone marrow stem cells

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

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: 1 year

Secondary outcomes

  1. Changes in the MRI knee with cartilage mapping and clinical improvement

    Time frame: Baseline, 6 months, 1 year

07

Study locations

1 site
  • St. Theresa's Hospital
    Bengaluru, Karnataka 560010, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01152125
Lead sponsor
International Stemcell Services Limited
First posted
Jun 29, 2010
Start date
Jan 2010
Primary completion
Aug 2011 (estimated)
Completion
Jan 2012 (estimated)
Last update
Jun 9, 2011

Study contacts

Rudraprasad, M.S
principal investigator · St. Theresa's Hospital
Alphy Zachson, M.B.B.S
study director · International Stemcell Services Limited

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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