Insulinized diabetic patients Pwith chronic critical ischemia in lower limbs MedDRA version: 14.1 Level: LLT Classification code 10012637 Term: Diabetes with peripheral circulatory disorders System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: Células mesenquimales de tejido adiposo
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: células mesenquimales de tejido adiposo autólogo
Concentration unit: ml millili
Sponsors
Fundación progreso y Salud
fundacion progreso y salud
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of the infusion intrarterial of mononuclear cells of bony marrow, cells CD133 + and cells mesenquimales of adipose tissue, on the inflammatory citoquinas, the resistance to the insulin and the decrease of the needs of this one, beside to evaluate the safety, viability and efficiency of the intra-arterial injection of cells in diabetic patients type 2. The aims of the study gather in efficiency and safety. - Safety: there will be evaluated the possible complications derived from the procedure in the first 24 hours after the administration of stem cells. - Efficiency: quantification of the degree of neovascularizacion (angio/arteriogenesis and vasculogenesis) to 6 months of the administration;Secondary Objective: There will be evaluated in four proposed groups, other clinical effects of the improvement expected from the vascularizacion by the cellular treatment (a) major amputation (supracondílea), minor and global during 12 months of evolution in the study (b) evolution of the ulcers(cicatrization or changes in his diameter), (c) transcutaneous pressure of oxygen, (d) clinical (score of pain in rest), (e) index ankle - arm, (f) perimeter gemelar, (g) test of march;Primary end point(s): MAIN VARIABLES: Insulinoterapy, Peptide C, Resistance to the insulin, inflammatory Citokinas, pancreatic Reservation, Index ABI, Walking test, Score of pain, transcutaneous Pressure of oxygen (TcPO2), Neuropathic Clinic.;Timepoint(s) of evaluation of this end point: 24 hours, 3, 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - SECONDARY variables: Arteriografía, AngioTAC, Temperature of the Member, Perimeter gemelar, Modifications of the trofismo, absence of major or minor amputation.;Timepoint(s) of evaluation of this end point: 24 hours, 3, 6 and 12 months. | — |
Countries
Spain
Contacts
Public Contactana cardesa
iniciativa andaluza en terapias avanzadas
Outcome results
None listed