Clinical Trial I/II Opened, Randomized and Controlled for the Study of the Use of Stem Cells Therapy in Insulinized Diabetic Patients Type 2 With Critical Ischemia in Lower Limbs (CLI): Study of the Needs of Insulin
NCT ID: NCT02287974
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2011-09-30
2018-07-31
Brief Summary
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Detailed Description
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Diabetic patients will include with critical ischemia chronicle of at least a low member limb (CLI) and without possibilities of revascularization. 48 evaluable patients will be included, of which 36 patients will be included in the experimental group (12 for every cellular group) and 12 in the group control by conventional treatment. The population to studying will be constituted by 48 evaluable patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Autologous mononuclear stem cell from the bone marrow
Autologous mononuclear stem cell from the bone marrow in an unique infusion of 150-250 millions of cells
Stem cell infusion
Unique stem cell infusion of the randomized group
Autologous endothelial stem cell from the bone marrow
Autologous endothelial progenitor CD133 stem cell from the bone marrow in an unique infusion of 2 - 7 millions of CD133 cells
Stem cell infusion
Unique stem cell infusion of the randomized group
Autologous mesenchymal stem cells from the adiposite tissue
Autologous mesenchymal stem cells from the adipose tissue in an unique infusion of 0.5 millions of cells
Stem cell infusion
Unique stem cell infusion of the randomized group
Current medication for the disease
Current medication for the disease
Stem cell infusion
Unique stem cell infusion of the randomized group
Interventions
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Stem cell infusion
Unique stem cell infusion of the randomized group
Eligibility Criteria
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Inclusion Criteria
2. Diabetic type 2, in treatment with insulin at least 3 previous months.
3. Vascular disease infrapopliteal atherosclerotic of severe degree (Patients with category Rutherford-Becker ≥ 4), pretty or bilateral. The critical ischemia of the foot is defined as a persistent / persistent pain that needs analgesia and / or not healing present sores\> 4 weeks, without evidence of improvement with conventional therapies and / or walking test between 1-6 minutes in two ergometries separated at least for 2 weeks and / or index ankle - arm in rest \<0,8.
4. Impossibility of revascularization surgical or endovascular or I fail in the surgery of revascularization performed at least 30 days before, with persistence or entry in phase of critical ischemia
5. Life expectancy \> 2 years.
6. Major amputation is not foreseen in any of the members in the next 6 months after the incorporation.
7. Normal Biochemical and bone marrow parameters defined for:
* Leukocytes ≥ 3000
* Neutrophils ≥ 1500
* Platelets ≥ 140000
* AST/ALT ≤ 2,5 standard range institution
* Creatinine ≤2,5 mg/dl and explanation of creatinine ≤ 30 ml/min (MDRD4)
8. The women in fertile age will have to obtain negative results in a pregnancy test realized in the moment of the incorporation in the study and promise to use a contraceptive method medically approved while the study lasts.
9. Patients who give his Informed Consent in writing for the participation in the study. 10. Patients who have not taken part in another clinical trial in the last 3 months before the incorporation.
Exclusion Criteria
2. Major previous amputation.
3. Patients with arterial uncontrolled hypertension (defined as arterial tension\> 180/110 in more than one occasion).
4. Cardiac severe insufficiency (NYHA the IVth) or Fraction of Ejection of left ventricle (FAITH) lower than 30 %.
5. Patients with ventricular malignant arrhythmias or unstable angina.
6. Diagnosis of venous deep thrombosis in 3 previous months.
7. Patients with genotype DD of the ECA or genotype E4 of the apo E.
8. Concomitant therapy that includes oxygen hyperbaric, vasoactive substances, agents against angiogenesis or inhibiting Cox-II. The agents use is allowed antiplatelets.
9. Index of corporal mass\> 40 Kg/m2.
10. Patients with the diagnosis of alcoholism in the moment of the incorporation.
11. Proliferative Retinopathy without possibility of treatment.
12. Diabetic Nephropathy with haemodialysis
13. Concomitant disease that reduces the life expectancy to less than 1 years.
14. Impossibility foreseen to obtain the inhaled one of 100ml of bone marrow.
15. Infection for HIV, Hepatitis B or Hepatitis C.
16. Impede in the follow-up.
17. ACV or heart attack of myocardium in the last 3 months
18. Anaemia (Haemoglobin \<7.9 g/dl)
19. Patients before treated with cellular therapy.
18 Years
85 Years
ALL
No
Sponsors
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Iniciativa Andaluza en Terapias Avanzadas
OTHER
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
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Principal Investigators
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Bernat Soria
Role: PRINCIPAL_INVESTIGATOR
CABIMER (Centro Andaluz de Biología Molecular y Medicina Regenerativa)
Locations
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Hopsital U. Virgen Macarena
Seville, Seville, Spain
CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)
Seville, , Spain
Countries
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Other Identifiers
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CeTMMoTa/ICPDI/2010
Identifier Type: -
Identifier Source: org_study_id