Stem cell tourism and spinal cord injury in South Africa.

Abstract

The publicity around stem cell therapy has given many persons who have sustained a devastating injury such as spinal cord injury (SCI) the hope of achieving partial or full recovery from their injuries. Several phase I and II clinical trials are being conducted owing to positive results obtained in animal models. While safety during the trials has been demonstrated, clinical efficacy in the outcome of ethically approved trials is still lacking. Many persons affected by SCI are, however, desperate for a cure and are lured into undergoing stem cell therapy by marketing campaigns and information readily available on the internet. These people travel far and wide to undergo stem cell therapy, which has led to the term 'stem cell tourism'.Objectives. To compare the data from participants' self-report questionnaires before and after their stem cell therapy to determine if there were differences in their functional and neurological status, and to record details of the procedures.Method. Persons who sustained a SCI and who received apparent stem cell therapy in South Africa (SA) or elsewhere were recruited to participate in the present study. Volunteers who gave written informed consent were asked to complete a biographical questionnaire and validated self-report questionnaire (Spinal Cord Independence Measure version III (SCIM III)) before and after their stem cell therapy to determine if there were differences in their functional and neurological status. The results of the self-report questionnaires were compared with the published expected functional outcome of people with lesions at a similar level of SCI to the participants. The secondary aims of the study were to document details of the procedures and their locations, the sources of 'stem cells' and the cost.Results. There was no indication that the participants' functional outcomes, as measured by the self-reported SCIM III, were better than the expected level of functional ability in patients with similar injury levels. Likewise, the neurological motor recovery scored on the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scores showed no improvement post stem cell therapy.Conclusion. This study highlights the need to curb the practice of offering unethical and non-evidence-based stem cell therapy for SCI. Ethical research and treatment is encouraged as well as an effective legal framework and education of health professionals, patients and their family members and caregivers, which will avoid unrealistic expectations, bogus therapies and the potential adverse effects of non-evidence-based 'stem cell therapies' offered by clinics via the internet.