Stem cell tourism and spinal cord injury in South Africa
Stem cell tourism and spinal cord injury in South Africa
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DOI：
10.7196/samj.2019.v109i8b.13824
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发表时间：
2019-08-01
影响因子：
2.2
通讯作者：
Pepper, M. S.
中科院分区：
文献类型：
--
作者：
Skeen, M.;Eksteen, C. A.;Pepper, M. S.
背景围绕干细胞治疗的宣传给了许多遭受破坏性损伤的人，如脊髓损伤（SCI），希望从他们的损伤中获得部分或完全康复。由于在动物模型中获得了积极的结果，目前正在进行几项第一和第二阶段临床试验。虽然试验期间的安全性已得到证明，但在伦理批准的试验结果中仍然缺乏临床疗效。然而，许多受SCI影响的人迫切需要治愈，并被互联网上的营销活动和信息引诱接受干细胞治疗。这些人旅行到很远很远的地方接受干细胞治疗，这导致了“干细胞旅游”这个术语。目的。比较参与者在干细胞治疗前后的自我报告问卷的数据，以确定他们的功能和神经系统状态是否存在差异，并记录程序的细节。在南非（SA）或其他地方接受明显干细胞治疗的SCI患者被招募参加本研究。提供书面知情同意书的志愿者被要求在干细胞治疗前后完成传记问卷和有效的自我报告问卷（脊髓独立性测量第三版（SCIM III）），以确定他们的功能和神经系统状态是否存在差异。自我报告问卷的结果与发表的预期功能结果的人在类似的SCI水平的参与者。该研究的次要目的是记录程序的细节及其位置，“干细胞”的来源和成本。没有迹象表明参与者的功能结果（通过自我报告的SCIM III测量）优于具有类似损伤水平的患者的预期功能水平。同样，脊髓损伤神经学分类国际标准（ISNCSCI）运动评分的神经运动恢复评分显示干细胞治疗后无改善。这项研究强调了遏制为SCI提供不道德和非循证干细胞治疗的必要性。鼓励伦理研究和治疗，以及有效的法律的框架和对卫生专业人员、患者及其家属和护理人员的教育，这将避免不切实际的期望、虚假的治疗和诊所通过互联网提供的无证据的“干细胞疗法”的潜在不良影响。
Background. 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.