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

Abstract

BackgroundHuman embryonic stem cells (hESCs) are pluripotent cells that have the potential to self-renew and differentiate into all types of human cells.PurposeThe present study was aimed at establishing the safety of hESC therapy in patients with terminal/incurable conditions.MethodsThis 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.ResultsA 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.ConclusionhESCs 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.

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“…The culturing of these cells requires no animal product, and it has not shown any adverse effects in any patient who has been transplanted with these cells. 14 The cell line has had more than 4000 passages, and aliquots of each passage have been stored for future reference. Cell viability after thawing has been a reason of concern worldwide as no standard protocol for freezing and thawing of hESCs has been established due to the different responses of different hESCs to the same freezing conditions.…”

“…The safety and efficacy of the cell line have already been established. 14 Assessment of cell viability is crucial for clinical therapy. In the present study, we will discuss the cell viability of the hESCs derived, maintained, and stored at our facility over a period of 9 years from 2007 to 2015.…”

Human Embryonic Stem Cells in Treatment of Spinal Cord Injury: A Prospective Study

“…The detailed procedure of cell culture and differentiation was elaborated previously [16]. The safety and efficacy of these cells has been established in patients with incurable conditions [17].…”

Role of Anesthetists in Human Embryonic Stem Cells Transplantation in Patients with Spinal Cord Injury

“…US 8592, 208, 52). All the SCI patients are treated as per our standardized protocol that has been validated after establishing safety and efficacy of hESC in SCI [16].…”