Critical Limb Ischemia Due to Buerger's DiseasePhase 2NCT03056742
A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
A Phase 2 study testing Stempeucel(R) in people with Critical Limb Ischemia Due to Buerger's Disease, run by Stempeutics Research Pvt Ltd at 8 sites in India.
Trial summary
This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of Cellular biology based therapeutic drug evaluation committee (CBBTDEC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Critical Limb Ischemia Due to Buerger's Disease
- What is being tested?
- Stempeucel(R)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesIndia
- Study dates
- 20 Feb 2017to Oct 2019
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Buerger's disease as diagnosed by Shionoya criteria
- Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs.
- Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5;
- Patients in Rutherford- III-6 if gangrene extending maximally up to the head of metatarsal but limited to toes (patients with wet gangrene must undergo wound debridement / amputation before screening) .
- Patients having infrapopliteal occlusive disease with rest pain and ischemic ulcer/necrosis (patients should have at least one measureable ulcer), who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients) .
- ABPI ≤ 0.6 or ankle pressure ≤ 50 mm Hg.
- Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent and video consent, abide by the study requirements, and agree to return for required follow-up visits.
Who cannot join
- Patients with CLI indicated for major amputation during screening
- Atherosclerotic PAD
- Ulcers with exposure of tendon and/bone in the shin region.
- Previous above trans metatarsal amputation in study limb
- Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening
- Patients with gait disturbance for reasons other than CLI
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- Diagnosis of diabetes mellitus (type 1 or type 2)
- Patients having left ventricular ejection fraction < 35%
- Patients suffering from clinically relevant peripheral neuropathy
- History of stroke or myocardial infarction
- Patients who are contraindicated for MRA
- Patients with DVT in any limb.
- Patients who 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 <1 year
- Patients already enrolled in another investigational drug trial or completed within 3 months or those who have received stem cells in the past
- Patient with known hypersensitivity to the constituents of the stempeucel®- dimethyl sulfoxide (DMSO) or human serum albumin (HSA)
- History of severe alcohol or drug abuse within 3 months of screening
- Hb% < 10 gm% for males, Hb% < 9 gm% for females, serum creatinine ≥ 2mg%, serum Total Bilirubin ≥2mg%
- Pregnant and lactating women
- Patients tested positive for HIV 1 \& 2, HCV, HBV, CMV, RPR antibodies and for HBsAg antigen
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, 560066
Department of Vascular Surgery, Madras Medical College
Chennai, Tamil Nadu, 600003
Department of Vascular Surgery, Sri Ramchandra Medical College
Chennai, Tamil Nadu, 600116
Saveetha Medical College & Hospital
Chennai, Tamil Nadu, 602105
SRM Medical College Hospital and Research Centre
Chennai, Tamil Nadu, 603203
Health Point Hospital
Kolkata, West Bengal, 700025
Nightingale Hospital
Kolkata, West Bengal, 700071
Department of Surgical Disciplines, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: A Single Arm, Open Label, Multicentric, Clinical Study Assessing the Efficacy and Safety of Stempeucel® (ex Vivo Cultured Adult Bone Marrow Derived Allogeneic Mesenchymal Stem Cells) in Patients With CLI Due to Buerger's Disease
This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of Cellular biology based therapeutic drug evaluation committee (CBBTDEC).
Read the detailed description
This study will evaluate the safety and efficacy of intramuscular injection of stempeucel(R) (Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells) in Critical Limb Ischemia due to Buerger's Disease
- Being tested
- Stempeucel(R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stempeucel(R)Biological
Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Stem cells | Experimental | Patients will receive intramuscular and local injection of stempeucel(R) in addition to standard protocol of care Receives: Biological: Stempeucel(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of the rest pain
Measured: 6 months
Reduction of ulcer area in the target limb
Measured: 6 months
Secondary outcomes (5)
Total walking distance
Measured: 6 months and 24 months
Major amputation free survival
Measured: 6 months and 24 months
Ankle brachial pressure index (ABPI) - measured by Doppler
Measured: 6 months and 24 months
Quality of life (QOL) by King's College VascuQOL questionnaire
Measured: 6 months and 24 months
Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)
Measured: 6 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start20 Feb 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: Form 46 from DCGI for the manufacturing \& commercial marketing of Stempeucel® directs Stempeutics to conduct PMS study. Hence this study is being terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb Ischemia Due to Buerger's DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stempeutics Research Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056742
- Sponsor's protocol ID
- SRPL/CLI/10-11/001 Version 4
- Status last verified
- Apr 2017
- First submitted
- 23 Jan 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Multicentric, Clinical Study Assessing the Efficacy and Safety of Stempeucel® (ex Vivo Cultured Adult Bone Marrow Derived Allogeneic Mesenchymal Stem Cells) in Patients With CLI Due to Buerger's Disease
- ClinicalTrials.gov ID
- NCT03056742
- Acronym / sponsor ID
- SRPL/CLI/10-11/001 Version 4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Form 46 from DCGI for the manufacturing \& commercial marketing of Stempeucel® directs Stempeutics to conduct PMS study. Hence this study is being terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stempeutics Research Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 17 Feb 2017 (actual)
- 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 study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of Cellular biology based therapeutic drug evaluation committee (CBBTDEC).
Detailed description
This study will evaluate the safety and efficacy of intramuscular injection of stempeucel(R) (Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells) in Critical Limb Ischemia due to Buerger's Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cells | Experimental | Biological: Stempeucel(R)Patients will receive intramuscular and local injection of stempeucel(R) in addition to standard protocol of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Buerger's disease as diagnosed by Shionoya criteria
- Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs.
- Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5;
- Patients in Rutherford- III-6 if gangrene extending maximally up to the head of metatarsal but limited to toes (patients with wet gangrene must undergo wound debridement / amputation before screening) .
- Patients having infrapopliteal occlusive disease with rest pain and ischemic ulcer/necrosis (patients should have at least one measureable ulcer), who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients) .
Key exclusion criteria (20 listed)
- Patients with CLI indicated for major amputation during screening
- Atherosclerotic PAD
- Ulcers with exposure of tendon and/bone in the shin region.
- Previous above trans metatarsal amputation in study limb
- Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening
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 |
|---|---|---|
| Stempeucel(R)Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells | Biological | Stem cells |
Primary outcome
Relief of the rest pain
Time frame: 6 months
Reduction of ulcer area in the target limb
Time frame: 6 months
5 secondary outcomes
Total walking distance
Time frame: 6 months and 24 months
Major amputation free survival
Time frame: 6 months and 24 months
Ankle brachial pressure index (ABPI) - measured by Doppler
Time frame: 6 months and 24 months
Quality of life (QOL) by King's College VascuQOL questionnaire
Time frame: 6 months and 24 months
Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)
Time frame: 6 months and 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Critical Limb Ischemia Due to Buerger's Disease
RecruitingPhase 4
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
Critical Limb Ischemia, Buerger's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stempeucel(R) in people with Critical Limb Ischemia Due to Buerger's Disease, run by Stempeutics Research Pvt Ltd at 8 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 20 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: withdrawn, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 phase mean?
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 was withdrawn before enrolling participants, so there are no results.
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?
Relief of the rest pain (time frame: 6 months). 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 7 Apr 2017.