AzTrials
AzTrials

Critical Limb IschemiaPhase 2NCT01484574

A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease

A Phase 2 study testing Allogeneic Mesenchymal Stem Cells in people with Critical Limb Ischemia and Buerger's Disease, run by Stempeutics Research Pvt Ltd at 10 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Critical Limb Ischemia, Buerger's Disease
What is being tested?
Allogeneic Mesenchymal Stem Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
10 sitesIndia
Study dates
Jan 2012to Mar 2016
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, who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients)
  • Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 50 mm Hg or TcPO2 ≤ 40 mmHg in the foot of the study limb
  • 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 transmetatarsal 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
Show all 20Show fewer
  • 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 deep vein thrombosis 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 participated in any stem cell clinical trial
  • Patient with known hypersensitivity to the constituents of the IMP - 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, HCV, HBV, CMV, RPR

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

India10 sites

  • Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals

    Bangalore, Karnataka, 560066

  • Peripheral Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research

    Bangalore, Karnataka, 560069

  • Department of Vascular Surgery, Madras Medical College

    Chennai, Tamil Nadu, 600003

  • Department of Vascular Surgery, Sri Ramchandra Medical College

    Chennai, Tamil Nadu, 600116

  • Department of Vascular Surgery, Stanley Medical College

    Chennai, Tamil Nadu, 91-44-24732266

  • Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity

    Gurgaon, Haryana, 122001

  • Department of Vascular Surgery, AMRI Hospital

    Kolkata, West Bengal, 700029

  • Nightingale Hospital

    Kolkata, West Bengal, 700071

  • Department of Surgery, KMC, Mangalore

    Mangalore, Karnataka, 575001

  • Department of Surgical Disciplines, All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029

Other trials in India

About this study

Official title: A Non-randomized, Open Label, Multicentric, Dose Ranging , Phase II Study Assessing the Efficacy and Safety of Intramuscular Administration of Stempeucel - CLI™ (ex Vivo Cultured Adult Bone Marrow Derived Allogeneic Mesenchymal Stem Cells) in Patients With Critical Limb Ischemia Due to Buerger's Disease

This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.

Being tested
Allogeneic Mesenchymal Stem Cells
Keywords
Critical limb ischemia, Buerger's disease, Critical limb ischemia due to Buerger's disease
Medical subject headings
Chronic Limb-Threatening Ischemia, Thromboangiitis Obliterans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogeneic Mesenchymal Stem CellsBiological

    Also called Stempeucel - CLI

    Single intramuscular administration of low dose of stem cells

  • Allogeneic Mesenchymal Stem CellsBiological

    Also called Stempeucel - CLI

    Single intramuscular administration of intermediate dose of stem cells

Study groups in NCT01484574
Study groupRoleWhat they receive
Low doseExperimentalStempeucel - CLI will be administered at the lowest dose
Receives: Biological: Allogeneic Mesenchymal Stem Cells
Intermediate doseExperimentalStempeucel - CLI will be administered at intermediate dose
Receives: Biological: Allogeneic Mesenchymal Stem Cells
Control armNo interventionStandard protocol of care alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relief of the rest pain

    Rest pain will be measured using rest pain scale (0 to10)

    Measured: 6 months

  2. Healing of ulcerations or reduction of ulcer area in the target limb

    Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.

    Measured: 6 months

  3. Relief of the rest pain

    Rest pain will be measured using rest pain scale (0 to 10)

    Measured: 24 months

  4. Healing of ulcerations or reduction of ulcer area in the target limb

    Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.

    Measured: 24 months

Secondary outcomes (10)

  1. Pain free walking distance

    Measured: 6 and 24 months

  2. Major amputation free survival

    Measured: 6 and 24 months

  3. Ankle brachial pressure index (ABPI) - measured by Doppler

    Measured: 6 and 24 months

  4. Increase in transcutaneous partial oxygen pressure (TcPO2)

    Measured: 6 and 24 months

  5. Quality of life by King's College VascuQOL questionnaire

    Measured: 6 and 24 months

  6. Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)

    Measured: 6 and 24 months

  7. The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).

    Measured: 6 and 24 months

  8. Assessment of clinical laboratory parameters

    Measured: 6 and 24 months

  9. Physical examination findings and assessment of vital signs

    Measured: 6 and 24 months

  10. Assessment of electrocardiogram (ECG) parameters

    Measured: 6 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionFeb 2014
  4. Study completionMar 2016

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01484574
Sponsor's protocol ID
SRPL/CLI/10-11/001
Status last verified
Sep 2016
First submitted
27 Nov 2011
Last updated
13 Sep 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Allogeneic Mesenchymal Stem Cells in people with Critical Limb Ischemia and Buerger's Disease, run by Stempeutics Research Pvt Ltd at 10 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: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 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?

Relief of the rest pain (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT01484574.

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 13 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in