Clinical trial phase I/II multicentric, open, randomized and controlled for the study of stem cells as therapy critical ischemia in low limbs in insulinized type 2 diabetic patients: study of the insuli

Phase 1

• Conditions: Insulinized diabetic patients Pwith chronic critical ischemia in lower limbs; MedDRA version: 14.1Level: LLTClassification code 10012637Term: Diabetes with peripheral circulatory disordersSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2010-019774-33-ES
• Lead Sponsor: Fundación progreso y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-12
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Age 18 and 85 years
2. Diabetic type 2, in treatment with insulin at least 3 previous months.
3. Vascular disease infrapoplítea aterosclerótica of severe degree (Patients with category Rutherford-Becker 4), mono or bilateral. The critical isquemia 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 ergometrías separated at least for 2 weeks and / or index ankle - arm in rest <0,8.
4. Impossibility of revascularización surgical or endovascular
5. Failure in the surgery of revascularización realized at least 30 days before, with persistence or entry in phase of isquemia critique
6. Life expectation> 2 years.
7. Major amputation is not foreseen in any of the members in the next 6 months after the recruitment.
8. Study trombofilia for the detection of possible factors protrombóticos
9. Biochemical parameters and of bony marrow normal, defined for:
- leukocytes 3000
-Neutrófilos 1500
- platelets 140000
-AST/ALT 2,5 standard range institution
-Creatinina 2,5 mg/dl and explanation of creatinina 30 ml/min (MDRD4)
10. 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.
11. Patients who give his Informed Consent in writing for the participation in the study.
12. Patients who have not taken part in another clinical trial in the last 3 months before the recruitment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. Precedent of neoplasia or hematologic disease (disease mieloproliferativa, syndrome mielodisplásico or leukaemia) in the last 2 years.
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 And.
8. Infection activates or infects humid the day of infusion of the cells.
9. Concomitant therapy that includes oxygen hiperbárico, substances vasoactivas, agents against angiogénesis or inhibiting Cox-II. The agents' use is allowed antiplaquetarios.
10. Index of corporal mass> 40 Kg/m2.
11. Patients with the diagnosis of alcoholism in the moment of the inclusion.
12. Retinopaty proliferative without possibility of treatment.
13. Diabetic Nefropatía with hemodiálisis
14. Concomitant disease that reduces the life expectation to less than 1 years.
15. Impossibility foreseen to obtain the inhaled one of 100ml of bony marrow.
16. Infection for HIV, Hepatitis B or Hepatitis C.
17. Difficluty to the follow-up.
18. ACV or heart attack of myocardium in the last 3 months
19. Anemia (Hemoglobin <7.9 g/dl)
20. Leucopenia
21. Trombocitopenia (<100000 plaquetas/l).
22. Patients treated prevously with cellular therapy
23. Pregnant women or in fertile age that they do not use contraceptive medically proven method.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified