Critical Limb IschemiaPhase 1/2NCT00883870
Mesenchymal Stem Cells in Critical Limb Ischemia
A Phase 1/2 study testing mesenchymal stem cells and Plasmalyte A in people with Critical Limb Ischemia, run by Stempeutics Research Pvt Ltd at 4 sites in India.
Trial summary
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- mesenchymal stem cells and Plasmalyte A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesIndia
- Study dates
- Apr 2009to Aug 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females with non-child bearing potential in the age group of 18-60 yrs of Indian origin.
- Established CLI, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients)
- Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 70 mm Hg or TcPO2 ≤ 60 mmHg in the foot
- Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8%) without complications
- Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits
- Normal liver and renal function
- On regular medication for hypertension if any
Who cannot join
- Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure and patients with any acute/chronic inflammatory condition
- CLI patient requiring amputation proximal to trans-metatarsal level
- Patients with gait disturbance for reasons other than CLI.
- Type I diabetes
- Patients having respiratory complications/left ventricular ejection fraction < 25%f) Stroke or myocardial infarction within last 3 months
- Patients who are contraindicated for MRA
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- Have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
- Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year
- Patients already enrolled in another investigational drug trial or completed within 3 months.
- History of severe alcohol or drug abuse within 3 months of screening.
- Hb% < 10 gm%, Serum Creatinine ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c > 8%
- Women with child bearing potential, pregnant and lactating women.
- Patients tested positive for HIV 1, HCV, HBV,
Trial locations and contacts
4 sites in 1 country.
India4 sites
M.S.Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054
Bhagawan Mahaveer Jain Heart Centre
Bangalore, Karnataka, 5660052
Amrita Institute of Medical Sciences
Kochi, Kerala, 682026
Sri Ganga Ram Hospital
New Delhi, New Delhi, 110060
About this study
Official title: A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intramuscular ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Critical Limb Ischemia (Cli)
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
- Conditions
- Critical Limb Ischemia
- Being tested
- mesenchymal stem cells, Plasmalyte A
- Keywords
- mesenchymal stem cells, critical limb ischemia
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellsDrug
Intramuscular injection
Plasmalyte ADrug
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stem cells | Experimental | Intramuscular injection Receives: Drug: mesenchymal stem cells |
| Placebo | Experimental | Intramuscular injection Receives: Drug: Plasmalyte A |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE and symptomatic relief
Measured: 6 months
Secondary outcomes (1)
Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stempeutics Research Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suresh K R, Principal investigator, Bhagawan Mahaveer Jain Heart Centre, BangaloreSanjay Desai, Principal investigator, M.S.Ramaiah Memorial Hospital, BangaloreRajiv Parakh, Principal investigator, Sri Ganga Ram Hospital, New DelhiSudhindran S, Principal investigator, Amrita Institute of Medical Sciences, Kochi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883870
- Sponsor's protocol ID
- SRPL/CLI/07-08/001
- Status last verified
- Mar 2013
- First submitted
- 17 Apr 2009
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gupta PK, Chullikana A, Parakh R, Desai S, Das A, Gottipamula S, Krishnamurthy S, Anthony N, Pherwani A, Majumdar AS. A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia. J Transl Med. 2013 Jun 10;11:143. doi: 10.1186/1479-5876-11-143.
PubMed 23758736
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intramuscular ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With Critical Limb Ischemia (Cli)
- ClinicalTrials.gov ID
- NCT00883870
- Acronym / sponsor ID
- SRPL/CLI/07-08/001
- Conditions
- Critical Limb Ischemia
- Keywords
- mesenchymal stem cells, critical limb ischemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stempeutics Research Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Apr 2009 (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.
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stem cells | Experimental | Drug: mesenchymal stem cellsIntramuscular injection |
| Placebo | Experimental | Drug: Plasmalyte AIntramuscular injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males or females with non-child bearing potential in the age group of 18-60 yrs of Indian origin.
- Established CLI, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients)
- Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 70 mm Hg or TcPO2 ≤ 60 mmHg in the foot
- Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8%) without complications
- Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits
Key exclusion criteria (13 listed)
- Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure and patients with any acute/chronic inflammatory condition
- CLI patient requiring amputation proximal to trans-metatarsal level
- Patients with gait disturbance for reasons other than CLI.
- Type I diabetes
- Patients having respiratory complications/left ventricular ejection fraction < 25%f) Stroke or myocardial infarction within last 3 months
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 |
|---|---|---|
| mesenchymal stem cellsIntramuscular injection | Drug | mesenchymal stem cells |
| Plasmalyte AIntramuscular injection | Drug | Placebo |
Primary outcome
AE and symptomatic relief
Time frame: 6 months
1 secondary outcome
Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Derived from this study: PubMed 23758736Gupta PK, Chullikana A, Parakh R, Desai S, Das A, Gottipamula S, Krishnamurthy S, Anthony N, Pherwani A, Majumdar AS. A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia. J Transl Med. 2013 Jun 10;11:143. doi: 10.1186/1479-5876-11-143.
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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.
Suresh K R principal investigator
Bhagawan Mahaveer Jain Heart Centre, Bangalore
Sanjay Desai principal investigator
M.S.Ramaiah Memorial Hospital, Bangalore
Rajiv Parakh principal investigator
Sri Ganga Ram Hospital, New Delhi
4 sites 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 mesenchymal stem cells and Plasmalyte A in people with Critical Limb Ischemia, run by Stempeutics Research Pvt Ltd at 4 sites 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 13 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: finished, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AE and symptomatic relief (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00883870, which also lists 1 linked publication.
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 5 Mar 2013.