Introduction: Congestive heart failure is one of the main causes of morbidity and mortality in the XXI century given the promising to date of ABMDSCs and HFDSCs we investigate the safety and efficacy for the implantation of those stem cells for the treatment of idiopathic cardiomyopathy. This is the first pilot clinical study to assess the safety and feasibility of HFDSC in humans. We totally implanted 13 patients: 3 patients were implanted with ABMDSC by Mini-invasive surgical technique in March 2004 in Montevideo, Uruguay, and 10 patients were implanted with HFDSCs by using 2 different surgical techniques: minimally invasive technique (1 patient) and full sternotomy technique (9 patients) between January and February of 2005 in Guayaquil Ecuador.
The HFDSCs were obtained from fetuses of 5 to 12 weeks´ gestation from legally consent, no compensated donors who have undergone terminated ectopic pregnancies, elective abortions, or spontaneous miscarriages. At that gestation´s period, totipotent stem cells´ fetus haven´t develop yet the HLA histocompatibility complex, so there´s no possible antigenicity between donor and recipient.
Results: Patients with HFDSCs improved in association with increased contractility in these regions. Compared with baseline assessments, we noted other improvements: The mean (±SD) NYHA class decreased from 3.4±0.5 to 1.33±0.5 (P=.001); the mean EF increased 31%, from 26.6% ± 4.0% to 34.8%±7.2% (P=.005); performance in the ETT increased 291.3%, from 4.25 minutes to 16.63 minutes (128.9% in metabolic equivalents, 2.45 to 5.63) (P<.0001); the mean LVEDD decreased 15%, from 6.85±0.6cm to 5.80±0.58cm (P<.001); mean performance in the 6-minute walk test increased 43.2%, from 251±113.1 seconds to 360±0 seconds (P=.01); the mean distance increased 64.4%, from 284.4±144.9m to 468.2±89.8m (P=.004); and the mean result in the Minnesota congestive HF test decreased from 71±27.3 to 6±5.9 (P<.001) The Kaplan-Maier probability of survival at 48 months was 66%.
It is not observed rejection, these patients have not developed malignance nodules or cancer at all in the follow-up. In the AMBCSs. The preoperative average NYHA functional class was 3.4; at. 6 months of follow up the average functional class value was 1.3 (p<0,005);. After 6 months all of them remained in functional class I/II. Baseline values of LVEF were 25,28 and 30%.; at 6 months increased to 38, 40 and 46%. (p<0,05). LVESV went from 50mm to 42mm (p<0.05). After 24 months, 2 of the patients still maintained this improvement, while the 3er patient returned to the earlier values after suffering from pneumonia. At 12 years and 5 months 2 patients are alive both received a Resynchronization Therapy; at 8 years and 3 months and 9 years and 1,6 month the actual average EF are 28 and 30 %. The 3er patient died of sudden death at 10 years after the implantation. We can´t demonstrate the cause of this sudden death.
Conclusion: Irrespective of the improvement seen in this study, it is still premature to determine accurately the mechanism of action, indications, doses and type of stem cells. Therefore, is imperative and extremely important that more research is needed.