Tuesday, December 4, 2012

Panel investigates unproven stem cell therapies #wscs12

A panel at the World Stem Cell Summit discussed the unproven uses of stem cells
 Tuesday morning the World Stem Cell Summit turned its attention to the use of “unproven” stem cells in clinics. This is an issue that has come to prominence in recent years, as clinics internationally and in the U.S. advertise (and charge high prices for) supposed stem cell treatments that have not been tested and shown to be effective, much less safe. (This is an issue we've blogged about quite a bit.)

In her introduction to the morning session, Ann Tsukamoto of StemCells, Inc. highlighted recent media reports concerning clinics where patient have been harmed by unproven cell treatments. Later in the session, Douglas Sipp from the RIKEN Center for Developmental Biology showed images of a stem cell clinic in the Dominican Republic that was clearly not practicing science-based medicine. The government has subsequently shut down the specific clinic.

James Guest from the University of Miami Miller School of Medicine said, “This is not something we can contain.” He felt excitement about stem cells coupled with the expansion of the internet has resulted "fast-track access" to unproven treatments. He showed examples where patents have been harmed from receiving these untested therapies. He noted that even in cases where transplanted cells are not harmful there is risk from transplant procedures that may result in damage to skin and tissue as well as infection.

The panel gave these signs of what they called a stem cell scam:
  • Claims of miracle cures for diseases
  • Single treatments or cells that can treat any type of disease
  • Lack of objective information, evidence (such as published medical reports) that a treatment is effective
  • Treatment by a doctor who is not trained or certified to treat the specific disease
  • No system exists to collect information and follow up with patients
Allan Wu from the Morrow Institute offered some ideas on what a patient can do if a university based clinical trail is not available and they want to consider a private-sector option. He indicated a consumer should ask:

  • Does the treating clinician have appropriate certificate to practice the procedure (But one need to watch out for certificates from organizations that are not authoritative)
  • Is the clinic FDA registered
  • Has the procedure they are considering been approved by an IRB, which is a panel that reviews experimental procedures
  •  Can they document results in other patients
Wu’s bottom line: You need to be able to ask your physician (1) have they done a significant number of procedures and (2) if I have a complication, will you be able to treat me? He also noted the International College of Stem Cell Medicine has formed to initiate an effort to certify doctors, laboratory directors and laboratories.

James Guest felt recent efforts to act against rogue clinics, educate patients and promote good practice has resulted in improved “adherence to accepted practices globally.” This is good news to go home on.

G.L.

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