The unregulated commercialization of stem cell treatments: a global perspective

Abstract

Research into the biological properties and clinical potential of stem cells has spurred strong public investment, industry development, media coverage, and patient interest in recent years. To date, however, few clinical applications of demonstrated safety and efficacy have been developed with the exception of uses of hematopoietic stem cells in the treatment of diseases of the blood and immune systems. This lack of an evidence basis notwithstanding, hundreds of companies and private clinics around the world now sell putative stem cell treatments for an enormously broad range of medical and quality-of-life conditions. This represents a major challenge for legitimate scientists working in the field, for authorities seeking to protect their constituencies, and for patients and consumers targeted by such companies’ marketing strategies. In this review, I provide an overview of the global industry in pseudomedical stem cell treatments, with an investigation of claims in a single disease area (amyotrophic lateral sclerosis), and make recommendations for the introduction and enforcement of appropriate regulatory responses to this problem.

Keywords

stem cell tourism / medical ethics / stem cell policy and regulation / alternative medicine

References

[1] PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM). Osiris Therapeutics. NCT00690066

[2] Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury. Stem Cells Inc. NCT01321333

[3] Pilot Investigation of Stem Cells in Stroke (PISCES). ReNeuron Ltd. NCT01151124

[4] Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS. The Cleveland Clinic. NCT00813969

[5] XCell-Center. Köln/Düsseldorf, Germany.

[6] Nova Cells Institute. Mexico.

[7] Wu Stem Cells Medical Center. Beijing, China.

[8] Rejuvenare. Dominican Republic.

[9] EmCell. Kiev, Ukraine.

[10] Stem Cell Therapies. USA/Mexico.

[11] CellPort Clinic. Yokohama, Japan.

[12] RecoverUp Stem cell Hair Regeneration. Scotland, UK.

[13] Repair Stem Cell Institute. Bangkok, Thailand.

[14] WIPO Patent. Compositions Comprising human embryonic stem cells and their derivatives, methods of use, and methods of preparation. WO 2007141657 20071213

[15] Blakely R. Stem cell experts sceptical of Dr Geeta Shroff’s miracle cure claims. The Times. London, UK. 7 Nov 2009.

[16] Medra Inc. Dominican Republic.

[17] Stem Cells for Hope. Mt. Sinai, NY, USA.

[18] Asian Stem Cell Regeneration Institute. Manila, The Philippines.

[19] Sipp D. Stem cell stratagems in alternative medicine. Regen Med 2011; 6(3): 407-414

[20] Jandial R, Snyder EY. A safer stem cell: on guard against cancer. Nat Med 2009; 15(9): 999-1001

[21] Ward V. Stem cell doctor Robert Trossel struck off medical register. The Daily Telegraph. London, UK. 30 Sep 2010.

[22] Kuznetsov V. Some Background on the Russian Stem Cell Market. Russia Blog. 25 June 2007.

[23] Cyranoski D. Stem-cell therapy faces more scrutiny in China. Nature 2009; 459(7244): 146-147

[24] Stem Cell Rejuvenation Center. Phoenix, AZ, USA.

[25] Clinic O. Tokyo, Japan.

[26] Biotechnology B. Shenzhen, China.

[27] Chaitanya Stem Cell Center. Pune, India.

[28] American Stem Cell & Anti-Aging Center. Quito, Ecuador.

[29] Stem Cell Institute. Panama City, Panama.

[30] Regenobody. Sosua, Dominican Republic.

[31] Tissü. Seychelles.

[32] Altaco XXI. Astana, Kazakhstan.

[33] Amni Health Services. Dubai, UAE.

[34] China Stem Cell News.

[35] Lau D, Ogbogu U, Taylor B, Stafinski T, Menon D, Caulfield T. Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. Cell Stem Cell 2008; 3(6): 591-594

[36] Zarzeczny A, Rachul C, Nisbet M, Caulfield T. Stem cell clinics in the news. Nat Biotechnol 2010; 28(12): 1243-1246

[37] Ryan KA, Sanders AN, Wang DD, Levine AD. Tracking the rise of stem cell tourism. Regen Med 2010; 5(1): 27-33

[38] Sipp D. The rocky road to regulation. Nature Rep Stem Cells 2009.

[39] Regenberg AC, Hutchinson LA, Schanker B, Mathews DJH. Medicine on the fringe: stem cell-based interventions in advance of evidence. Stem Cells 2009; 27(9): 2312-2319

[40] Kiatpongsan S, Sipp D. Medicine. Monitoring and regulating offshore stem cell clinics. Science 2009; 323(5921): 1564-1565

[41] Japanese Society for Regenerative Medicine. (Japanese language announcement)

[42] Gunter KC, Caplan AL, Mason C, Salzman R, Janssen WE, Nichols K, Bouzas LF, Lanza F, Levine BL, Rasko JE, Shimosaka A, Horwitz E. Cell therapy medical tourism: time for action. Cytotherapy 2010; 12(8): 965-968

[43] Taylor PL, Barker RA, Blume KG, Cattaneo E, Colman A, Deng H, Edgar H, Fox IJ, Gerstle C, Goldstein LS, High KA, Lyall A, Parkman R, Pitossi FJ, Prentice ED, Rooke HM, Sipp DA, Srivastava A, Stayn S, Steinberg GK, Wagers AJ, Weissman IL. Patients beware: commercialized stem cell treatments on the web. Cell Stem Cell 2010; 7(1): 43-49

[44] A closer look at stem cells.

[45] Carroll R. Costa Rican health ministry bans experimental stem cell treatment. Guardian. London, UK. 7 June (2010)

[46] Sheldon T. The Netherlands bans private stem cell therapy. BMJ 2007; 334(7583): 12

[47] Than K. Hungary detains 4 over illegal stem cell treatment. Reuters 29 Jul 2009.

[48] Sirisunthon S, Sarnsamak P. Medical Council issues new decree to control stem cell research. The Nation. Bangkok, Thailand. 29 May 2009.

[49] Cyranoski D. Stem-cell therapy faces more scrutiny in China. Nature 2009; 459(7244): 146-147

[50] Heyer M. Do therapies based on the application of the body’s own adult stem cells need authorization or approval? An evaluation.

[51] Kawakami M, Sipp D, Kato K. Regulatory impacts on stem cell research in Japan. Cell Stem Cell 2010; 6(5): 415-418

[52] Progencell. San Diego, CA, USA.

[53] Regenocyte. Bonita Springs, FL, USA.

[54] Koustas WT. Rdegenerative Sciences faced with FDA injunction. FDA Law Blog 21 Aug 2010.

[55] ICMS. Open Letter to Stem Cell Clinics. 2 Aug 2010.

[56] Koustas WT. Regenerative Sciences, Inc. attempts to avoid FDA action. FDA Law Blog 27 Jun 2010.

[57] Integra Medical Center. Nuevo Progreso, Mexico.

[58] Healing the Eye. Cave Creek, AZ, USA.

[59] Stem Cell Natural Therapy. Chiang Mai, Thailand.

[60] Kim D. CO, USA.

[61] Dedeepiya V, John S, Abraham S. The gravity of regenerative medicine; Physics, chemistry & Biology behind it. J of Stem Cells and Regen Med 2008. 6(1) 22-23.

[62] Best Stem Cell Therapies. India.

[63] BioPathics. Palm Beach Gardens, FL, USA.

[64] Unproven methods of cancer management: Fresh cell therapy. CA - A Cancer Journal for Clinicians. 31 Dec 2008.

[65] Rowland LP, Shneider NA. Amyotrophic lateral sclerosis. N Engl J Med 2001; 344: 1688-1700

[66] Dunckley T, Huentelman MJ, Craig DW, Pearson JV, Szelinger S, Joshipura K, Halperin RF, Stamper C, Jensen KR, Letizia D, Hesterlee SE, Pestronk A, Levine T, Bertorini T, Graves MC, Mozaffar T, Jackson CE, Bosch P, McVey A, Dick A, Barohn R, Lomen-Hoerth C, Rosenfeld J, O’connor DT, Zhang K, Crook R, Ryberg H, Hutton M, Katz J, Simpson EP, Mitsumoto H, Bowser R, Miller RG, Appel SH, Stephan DA. Whole-genome analysis of sporadic amyotrophic lateral sclerosis. N Engl J Med 2007; 357(8): 775-788

[67] Miller RG, Mitchell JD, Lyon M, Moore DH. Riluzole for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND). Cochrane Database Syst Rev 2007; (1): CD001447

[68] Emory ALS. Center. Atlanta, GA, USA.

[69] Vlieland ND, Haberland N, Sipos L, Tamaschke UK, Happich D, Kleinbloesem CH. Autologous Stem Cell Transplantation in patients with Amyotrophic Lateral Sclerosis. (poster presentation).

[70] ALSUntangled Group. ALSUntangled update 4: investigating the XCell-Center. Amyotroph Lateral Scler 2010; 11(3): 337-338

[71] Biotechnology B. Patient Information Guide Summer 2010.

[72] Biotechnology B. Clinical Studies webpage.

[73] US Code of Federal Regulations Title 21, Part 1271.

[74] Patra PK, Sleeboom-Faulkner M. Bionetworking: Between Guidelines and Practice in Stem Cell Therapy Enterprise in India. (2010) 7:2 SCRIPTed 295,

[75] Cyranoski D. Korean deaths spark inquiry. Nature 2010; 468(7323): 485

[76] Sipp D. Stem cell research in Asia: a critical view. J Cell Biochem 2009; 107(5): 853-856

[77] VesCell press release. Stem cell plant to bring treatment to thousands. 13 Oct 2005.

[78] ISSCR. Patient handbook on stem cell therapies.

[79] International Campaignfor Cures of Spinal Cord Inury Paralysis (ICCP). Experimental treatments for spinal cord injury: What you should know.

[80] UK Multiple Sclerosis Society. Stem cell therapies in MS.

[81] Worldwide ALS. A Patient’s guide through the maze of stem cell transplantation.

[82] UK Multiple Sclerosis Society. MS Society warning over ‘stem cell’ treatments. 2 Dec 2008.

[83] Zarembo A. A desperate injection of stem cels and hope. Los Angeles Times 20 Feb 2005.

[84] Panorama BBC. Stem cells and miracles. 18 May 2009.

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