Cardiac stem cell therapy among Clinics of Uncertain Regulatory Status (COURS): under-regulated, under-observed, incompletely understood
Abstract Background Although a large body of information exists relating to cellular therapies, much of this information is either anecdotal or has been obtained from relatively small clinical trials, so that the level of evidence available to direct adoption of therapeutic approaches is quite limit...
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| Format: | Article |
| Language: | English |
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BMC
2020-07-01
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| Series: | Journal of Translational Medicine |
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| Online Access: | http://link.springer.com/article/10.1186/s12967-020-02425-6 |
| _version_ | 1818215896902008832 |
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| author | Amanda Lindeman Carl J. Pepine Keith L. March |
| author_facet | Amanda Lindeman Carl J. Pepine Keith L. March |
| author_sort | Amanda Lindeman |
| collection | DOAJ |
| description | Abstract Background Although a large body of information exists relating to cellular therapies, much of this information is either anecdotal or has been obtained from relatively small clinical trials, so that the level of evidence available to direct adoption of therapeutic approaches is quite limited. Despite this, a large number of clinics offer various cellular treatments without having gone through the processes of FDA approval. Florida is considered a “hotspot” of such sites, with a large number of clinics relative to the population. Methods To better understand the magnitude and scope of this issue with a specific focus on cardiovascular disease, we surveyed clinics in Florida advertising “cell therapy for heart failure”. We identified only 8 clinics that “treat cardiac conditions, including heart failure.” Data on administration route, cell type used, dose, success rate, cost, and training of persons performing procedures were collected when available, via email, telephone, or website information. Results A total of 20,135 patients were identified as treated: 2157 for cardiac conditions. All clinics reported administering cells intravenously, using either adipose- or umbilical-derived sources. Doses ranged from 30 to 150 million cells per treatment. The “success rate” ranged from 65 to 85%, with costs from $6000 to $20,700. Procedures were performed by PAs, MDs, and DOs. Conclusion Large numbers of patients (> 10% of all 20,135 patients) have been and presumably are still are being treated for “cardiac conditions.” We conclude that implementation of uniform data collection with an outcome registry, as well as creation of a public database listing FDA-approved cell-based clinical trials, would be useful to patients and the cardiovascular field at large. |
| first_indexed | 2024-12-12T06:43:22Z |
| format | Article |
| id | doaj.art-8495f63d4ab7460ca2201d6fbd3ef7a8 |
| institution | Directory Open Access Journal |
| issn | 1479-5876 |
| language | English |
| last_indexed | 2024-12-12T06:43:22Z |
| publishDate | 2020-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Translational Medicine |
| spelling | doaj.art-8495f63d4ab7460ca2201d6fbd3ef7a82022-12-22T00:34:16ZengBMCJournal of Translational Medicine1479-58762020-07-011811710.1186/s12967-020-02425-6Cardiac stem cell therapy among Clinics of Uncertain Regulatory Status (COURS): under-regulated, under-observed, incompletely understoodAmanda Lindeman0Carl J. Pepine1Keith L. March2University of Florida Center for Regenerative MedicineUniversity of Florida Center for Regenerative MedicineUniversity of Florida Center for Regenerative MedicineAbstract Background Although a large body of information exists relating to cellular therapies, much of this information is either anecdotal or has been obtained from relatively small clinical trials, so that the level of evidence available to direct adoption of therapeutic approaches is quite limited. Despite this, a large number of clinics offer various cellular treatments without having gone through the processes of FDA approval. Florida is considered a “hotspot” of such sites, with a large number of clinics relative to the population. Methods To better understand the magnitude and scope of this issue with a specific focus on cardiovascular disease, we surveyed clinics in Florida advertising “cell therapy for heart failure”. We identified only 8 clinics that “treat cardiac conditions, including heart failure.” Data on administration route, cell type used, dose, success rate, cost, and training of persons performing procedures were collected when available, via email, telephone, or website information. Results A total of 20,135 patients were identified as treated: 2157 for cardiac conditions. All clinics reported administering cells intravenously, using either adipose- or umbilical-derived sources. Doses ranged from 30 to 150 million cells per treatment. The “success rate” ranged from 65 to 85%, with costs from $6000 to $20,700. Procedures were performed by PAs, MDs, and DOs. Conclusion Large numbers of patients (> 10% of all 20,135 patients) have been and presumably are still are being treated for “cardiac conditions.” We conclude that implementation of uniform data collection with an outcome registry, as well as creation of a public database listing FDA-approved cell-based clinical trials, would be useful to patients and the cardiovascular field at large.http://link.springer.com/article/10.1186/s12967-020-02425-6Stem cellCell therapyHeart failureAdipose stem cellCardiovascular disease |
| spellingShingle | Amanda Lindeman Carl J. Pepine Keith L. March Cardiac stem cell therapy among Clinics of Uncertain Regulatory Status (COURS): under-regulated, under-observed, incompletely understood Journal of Translational Medicine Stem cell Cell therapy Heart failure Adipose stem cell Cardiovascular disease |
| title | Cardiac stem cell therapy among Clinics of Uncertain Regulatory Status (COURS): under-regulated, under-observed, incompletely understood |
| title_full | Cardiac stem cell therapy among Clinics of Uncertain Regulatory Status (COURS): under-regulated, under-observed, incompletely understood |
| title_fullStr | Cardiac stem cell therapy among Clinics of Uncertain Regulatory Status (COURS): under-regulated, under-observed, incompletely understood |
| title_full_unstemmed | Cardiac stem cell therapy among Clinics of Uncertain Regulatory Status (COURS): under-regulated, under-observed, incompletely understood |
| title_short | Cardiac stem cell therapy among Clinics of Uncertain Regulatory Status (COURS): under-regulated, under-observed, incompletely understood |
| title_sort | cardiac stem cell therapy among clinics of uncertain regulatory status cours under regulated under observed incompletely understood |
| topic | Stem cell Cell therapy Heart failure Adipose stem cell Cardiovascular disease |
| url | http://link.springer.com/article/10.1186/s12967-020-02425-6 |
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