Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.
Clinical Trial Phase I / II, Multicentre, Open, Randomized Study of the Use of Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Critical Chronic Ischemic Syndrome of Lower Limb in Nondiabetic Patients.
2 other identifiers
interventional
33
1 country
2
Brief Summary
Clinical trial phase I / II, prospective, multicenter, open, randomized, parallel-groups controlled by two levels of dose to assess the safety and feasibility of the infusion of mesenchymal stem cells from adipose tissue administered intra-arterially in nondiabetic patients with chronic ischemia of lower limbs (CLI) and no possibility of revascularization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2011
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 3, 2012
CompletedFirst Posted
Study publicly available on registry
December 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJuly 9, 2018
July 1, 2018
7.4 years
December 3, 2012
July 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of adverse events and serious adverse events
Number of adverse events and serious adverse events: 24h administration of CeTMAd, 1 month, 3 months, 6 months, 9 months and 12 months.
12 months.
Secondary Outcomes (1)
Evolution of chronic critical ischemia
1 month, 3 months, 6 months, 9 months and 12 months
Study Arms (3)
Low dose
EXPERIMENTAL\- Infusion of mesenchymal stem cells from adipose tissue: 0.5x106 cells / kg of patient weight.
High dose
EXPERIMENTAL\- Infusion of mesenchymal stem cells from adipose tissue: 1x106 cells / kg of patient weight.
Control
NO INTERVENTIONConventional treatment
Interventions
\- Infusion of mesenchymal stem cells from adipose tissue administered intraarterially: 0.5x106 cells / kg of patient weight and 1x106 cells / kg of patient weight.
Eligibility Criteria
You may qualify if:
- Patients of both sexes aged ≥ 18 and ≤ 89 years.
- Nondiabetic.
- Infrapopliteal atherosclerotic vascular disease of severe grade with either severe claudication or Rutherford-Becker grade II-III-IV, of at least one lower limb. It is defined critical ischemia of the lower limb as persistent/recurrent pain requiring analgesia and / or non-healing present ulcers \> 4 weeks, with no evidence of improvement with conventional therapies and / or walking test (stress test) between 1-6 minutes in two exercise tests separated by at least 2 weeks and / or ankle-brachial index at rest \<0.8.
- Inability of surgical or endovascular revascularization as recommended by the TransAtlantic InterSociety Consensus (TASC).
- Failure in the revascularization surgery performed at least 30 days before, with persistence or entry in critical ischemia phase.
- Life expectancy\> 2 years.
- Normal biochemical parameters defined by:
- Leukocytes ≥ 3000
- Neutrophils ≥ 1500
- Platelets ≥ 100,000
- Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 2.5 standard range institution
- Creatinine ≤ 2.5 mg / dl.
- Patients give their written informed consent to participate in the study.
You may not qualify if:
- History of malignancy or hematologic disease (myeloproliferative disease, myelodysplastic syndrome or leukemia) in the last two years.
- Patients with uncontrolled hypertension (defined as blood pressure\> 180/110 on more than one occasion).
- Severe heart failure (New York Heart Association class IV) or ejection fraction of the left ventricle less than 30%.
- Patients with malignant ventricular arrhythmias or unstable angina at the time of infusion.
- Diagnosis of deep vein thrombosis in the previous 3 months.
- Active infection or wet gangrene at day of infusion of Mesenchymal Stem Cells from Adipose Tissue.
- Concomitant therapy including hyperbaric oxygen. It is allowed the use of antiplatelet agents.
- Body mass index\>40 kg/m2.
- Untreated proliferative retinopathy.
- Concomitant disease that reduces life expectancy to less than a year.
- Predicted impossibility to obtain a biopsy providing 10 g of adipose tissue.
- human immunodeficiency virus, hepatitis B virus or hepatitis C virus.
- Difficulty in monitoring.
- Stroke or myocardial infarction within the last 3 months.
- Anemia (hemoglobin \<7.9 mg / dl).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital San Lazaro
Seville, 41009, Spain
University Hospital Virgen Macarena
Seville, 41009, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael J. Ruiz-Salmerón
Hemodynamics Unit. Hospital Universitario Virgen Macarena.
- PRINCIPAL INVESTIGATOR
Antonio de la Cuesta
Chronic Critical Ischemia Unit. San Lazaro Hospital.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2012
First Posted
December 10, 2012
Study Start
February 1, 2011
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
July 9, 2018
Record last verified: 2018-07