DIABETES MELLITUS & AUTOLOGOUS BONE MARROW PROGENITOR CELL TRANSPLANT. THE CONZI’S EFFECT (TM). COOPERATIVE MULTICENTER STUDY

JE Novoa, F Perez Chavez, MA Medina, M Soto, R Estela, J Ravera, F Gordillo, B Steffano, A Perez Chavez, P Alterwain, A Ortega, F Martinez & R Caride

Depto.de Medicina Interna, Servicio de Hematología & Angiogénesis Terapéutica, Hospital Policial-DNSP, Hospital de San Carlos, MSP-ASSE, Centro de Terapia Celular Clinica Real. Montevideo, Uruguay.Departamento de Patologia Clinica & Servicios Médicos. UANL, Monterrey, Mexico.

Background: diabetes mellitus accounts for more than 250 million people all around the world. It represents a pandemia, with important consequences over the health systems. The conventional treatment includes a complex strategy combining physical exercise, diet, oral hypoglucemiants and or insuline. The efficacy of this therapies is decreassing with the outcome of the disease and the parenchimal consequences appear progressevely (blindness, lower limb amputation, chronic renal failure, acute myocardial infarction, stroke, etc.). Aims a)primary: improve de quality of life in diabetic patients, types 1 and 2 (methabolic control, dose reduction or suspention of hypoglucemiant drugs, and quality of life indexes-ql), b)secondary: to evaluate other aditional therapeutic effects and c) evaluate side effects to the procedure (AMBPCT). Methods: from july 2004 to november 2007, 145 diabetic patients were evaluable to be included on this study. 75 men and 70 women. Median age was 66 years old (8 – 85). 55 patients from Uruguay (FEMI, MSP) and 90 from México (UANL). Type 1, 29 patients and type 2 116. All the patients signed informed consent. Were excluded patients with cancer in the last five years, degree IV diabetic retinopathy, active somking, morbid obesity and short life (less than 6 months) expectancy.Local anaesthesia was employed in 141/145 patients, with xilocaine 2% (for harvest and transplantation in the gastrocnemius muscle). Cell concentration was obtained by gradient of density. Mobilization with filgrastim was emloyed, 5 ug/kg/weight in two doses before transplantation (48 hs). Unmanipulated progenitor bone marrow cells were injected in one of the lower limbs in 2 ml aliquots. Mean volume of harvest was 2,8 ml/kg/body weight. The mean number of transplanted mononuclear cells was 2,4×109/kg body weight. All the patients received after ABMPCT, nadroparine 3800 IU anti-Xa s/c, clopidogrel 75 mg/daily and pentoxiphilin 400 mg/daily during 30 days. Each patient was evaluated regularly for glicemia, A1c Hemoglobin, C peptide and BMI (body mass index). Results: there were no deaths secondary to the treatment. The only complication of the procedure was local hemathoma in the trasplanted leg (4.25%). Results: 44% of type 1 diabetic patients discontinued the insulin treatment after 120 days post ABMPCT for more than 5 months. 85% of type 2 diabetic patients discontinued the oral hypoglucemiants or insulin after 120 days post ABMPCT for more than 5 months. Conclusions: autologous bone marrow progenitor cell transplant by the Conzi’s effect, can be performed safely and appears to be a benefical complementary therapy for human diabetes mellitus.

In Press: Thrombosis & Haemostasis (accepted to be published)
XX CLAHT Congress. Buenos Aires, Argentina. 23 – 28 abril de 2008

Acerca De Nosotros Contacto Novedades

CellTher.org - © 2008 Terapia Celular. Arteriopatía, Diabetes y Parkinson – CellTher.org - Zombie Designs