Safety of human embryonic stem cells in patients with terminal/incurable conditions- a retrospective analysis

BACKGROUND: Human embryonic stem cells (hESCs) are pluripotent cells that have the potential to self-renew and differentiate into all types of human cells. PURPOSE: The present study was aimed at establishing the safety of hESC therapy in patients with terminal/incurable conditions. METHODS: This was a single cohort study conducted at Nutech Mediworld, New Delhi. The patients suffering from various degenerative diseases were included in the study from year 2002 to 2004. hESCs (0.25 mL) were injected under skin in the abdominal wall. The safety of hESC therapy was evaluated by assessing the AEs experienced by patients during the study. Any disabling symptom/ sign, teratoma or antigen-antibody reaction that a patient suffered post transplantation of hESCs was considered as an AE. RESULTS: A total of four, six and twenty three patients received hESC therapy in the year 2002, 2003 and 2004 respectively. Pain and fever were the most common AEs observed during the study. Other AEs included headache, mild pain in the abdomen, swelling of legs (edema), urinary tract infection (UTI), rash/erythema, pain at the lower back and limbs and body ache. All the AEs reported were mild in nature and resolved within one or two days with symptomatic medication and rest. No serious AEs were reported. The improvement in specific parameters of the patients was observed after the therapy. CONCLUSION: hESCs used in the present study are safe for use in humans afflicted with incurable/terminal conditions. Future, prospective controlled studies to substantiate the present study are ongoing.