OsteoarthritisPhase 1/2NCT01152125
Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Osteoarthritis
A Phase 1/2 study testing Autologous bone marrow stem cells in people with Osteoarthritis, run by International Stemcell Services Limited at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Autologous bone marrow stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2010to Jan 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Autologous Bone Marrow Stem Cell Transplantation for Therapeutic Chondrogenesis in Moderate to Severe Osteoarthritis - ABM & LAM ST-OA Study
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.
Read 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
- Being tested
- Autologous bone marrow stem cells
- Keywords
- Osteoarthritis, stem cell implantation, bone marrow, autologous
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow stem cellsOther
Stem cells isolated from the patient's own bone marrow.
| Study group | Role | What they receive |
|---|---|---|
| Autologous bone marrow stem cells | Experimental | Not described Receives: Other: Autologous bone marrow stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
Measured: Baseline, 3 months, 6 months, 1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 1 year
Secondary outcomes (1)
Changes in the MRI knee with cartilage mapping and clinical improvement
Measured: Baseline, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Stemcell Services Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rudraprasad, M.S, Principal investigator, St. Theresa's HospitalAlphy Zachson, M.B.B.S, Study director, International Stemcell Services Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152125
- Sponsor's protocol ID
- ISSL-AuBM-OA
- Status last verified
- Jun 2011
- First submitted
- 25 Jun 2010
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Bone Marrow Stem Cell Transplantation for Therapeutic Chondrogenesis in Moderate to Severe Osteoarthritis - ABM & LAM ST-OA Study
- ClinicalTrials.gov ID
- NCT01152125
- Acronym / sponsor ID
- ISSL-AuBM-OA
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, stem cell implantation, bone marrow, autologous
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- International Stemcell Services LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous bone marrow stem cells | Experimental | Other: Autologous bone marrow stem cells |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous bone marrow stem cellsStem cells isolated from the patient's own bone marrow. | Other | Autologous bone marrow stem cells |
Primary outcome
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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 1 year
1 secondary outcome
Changes in the MRI knee with cartilage mapping and clinical improvement
Time frame: Baseline, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudraprasad, M.S principal investigator
St. Theresa's Hospital
Alphy Zachson, M.B.B.S study director
International Stemcell Services Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous bone marrow stem cells in people with Osteoarthritis, run by International Stemcell Services Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2011; AzTrials last refreshed its copy on 8 Nov 2026.