Abstract
The promise of stem cell (SC) therapies to restore functions of damaged tissues and organs brings enormous hope to patients, their families, loved ones, and caregivers. However, limits may exist for which indications SC therapies might be useful, efficacious, and safe. Applications of innovative therapies within regulatory boundaries and within the framework of controlled clinical trials are the norm in the scientific and medical community; such a system minimizes patient risk by setting a clear and acceptable safety and efficacy profile for new therapeutics before marketing authorization. This careful clinical validation approach often takes time, which patients suffering from terminal or debilitating diseases do not have. Not validated, unproven stem cell interventions (SCI) that promise a working treatment or cure for severe diseases have therefore found their way into the patient community, and providers of such treatments often take advantage of the public's willingness to pay large amounts of money for the misguided hope of a reliable recovery from their illnesses. We conducted a review of scientific publications, clinical case reports, and mass media publications to assess the reported cases and safety incidents associated with unproven SCI. The review also analyzes the main factors that were identified as contributing to the emergence and global rise of the “stem cell tourism” phenomenon. Stem Cells Translational Medicine 2018;1–10.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 676-685 |
| Number of pages | 10 |
| Journal | Stem cells translational medicine |
| Volume | 7 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 1 2018 |
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Keywords
- Adverse events
- Clinical trials
- Ethics
- Hype
- Mesenchymal stromal cells
- Regulations
- Risks
- Stem cell clinics
- Stem cell tourism
- Stem cells
- Unproven interventions
ASJC Scopus subject areas
- Developmental Biology
- Cell Biology
Cite this
Concise Review : A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions. / Bauer, Gerhard; Elsallab, Magdi; Abou-El-Enein, Mohamed.
In: Stem cells translational medicine, Vol. 7, No. 9, 01.09.2018, p. 676-685.Research output: Contribution to journal › Review article
}
TY - JOUR
T1 - Concise Review
T2 - A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions
AU - Bauer, Gerhard
AU - Elsallab, Magdi
AU - Abou-El-Enein, Mohamed
PY - 2018/9/1
Y1 - 2018/9/1
N2 - The promise of stem cell (SC) therapies to restore functions of damaged tissues and organs brings enormous hope to patients, their families, loved ones, and caregivers. However, limits may exist for which indications SC therapies might be useful, efficacious, and safe. Applications of innovative therapies within regulatory boundaries and within the framework of controlled clinical trials are the norm in the scientific and medical community; such a system minimizes patient risk by setting a clear and acceptable safety and efficacy profile for new therapeutics before marketing authorization. This careful clinical validation approach often takes time, which patients suffering from terminal or debilitating diseases do not have. Not validated, unproven stem cell interventions (SCI) that promise a working treatment or cure for severe diseases have therefore found their way into the patient community, and providers of such treatments often take advantage of the public's willingness to pay large amounts of money for the misguided hope of a reliable recovery from their illnesses. We conducted a review of scientific publications, clinical case reports, and mass media publications to assess the reported cases and safety incidents associated with unproven SCI. The review also analyzes the main factors that were identified as contributing to the emergence and global rise of the “stem cell tourism” phenomenon. Stem Cells Translational Medicine 2018;1–10.
AB - The promise of stem cell (SC) therapies to restore functions of damaged tissues and organs brings enormous hope to patients, their families, loved ones, and caregivers. However, limits may exist for which indications SC therapies might be useful, efficacious, and safe. Applications of innovative therapies within regulatory boundaries and within the framework of controlled clinical trials are the norm in the scientific and medical community; such a system minimizes patient risk by setting a clear and acceptable safety and efficacy profile for new therapeutics before marketing authorization. This careful clinical validation approach often takes time, which patients suffering from terminal or debilitating diseases do not have. Not validated, unproven stem cell interventions (SCI) that promise a working treatment or cure for severe diseases have therefore found their way into the patient community, and providers of such treatments often take advantage of the public's willingness to pay large amounts of money for the misguided hope of a reliable recovery from their illnesses. We conducted a review of scientific publications, clinical case reports, and mass media publications to assess the reported cases and safety incidents associated with unproven SCI. The review also analyzes the main factors that were identified as contributing to the emergence and global rise of the “stem cell tourism” phenomenon. Stem Cells Translational Medicine 2018;1–10.
KW - Adverse events
KW - Clinical trials
KW - Ethics
KW - Hype
KW - Mesenchymal stromal cells
KW - Regulations
KW - Risks
KW - Stem cell clinics
KW - Stem cell tourism
KW - Stem cells
KW - Unproven interventions
UR - http://www.scopus.com/inward/record.url?scp=85052795693&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85052795693&partnerID=8YFLogxK
U2 - 10.1002/sctm.17-0282
DO - 10.1002/sctm.17-0282
M3 - Review article
C2 - 30063299
AN - SCOPUS:85052795693
VL - 7
SP - 676
EP - 685
JO - Stem cells translational medicine
JF - Stem cells translational medicine
SN - 2157-6564
IS - 9
ER -