It’s been an eventful year already for those interested in stem cell research in Texas, and representatives from Texans for the Advancement of Medical Research (TAMR) have been heavily involved as Texas makes decisions on critical issues about the future of research in our state. Here’s a quick rundown of what’s going on in Texas:
New Rules on Adult Stem Cells
In April, the Texas Medical Board approved new rules governing the use of adult stem cells. The rules allow doctors to use stem cells as long as they get the approval of a review board that evaluates clinical research for safety.
Since their adoption, the rules have been criticized by some for setting “a very low bar for approval of experimental procedures.” TAMR’s major concern throughout the rule-making process has been to make certain that patients are fully protected and fully informed. We have insisted that standard of care for patients must be the “gold” standard, and patients must provide fully informed consent before treatment has begun.
Further, TAMR representatives monitored the entire process to ensure that no rules were promulgated that restrict stem cell research in any of its forms. Under the new rules, all forms of stem cell research continue to be legal in Texas.
The rules officially went into effect last week. They can be reviewed here.
“Texas board approves rules on use of stem cells”
New York Times
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“Conflicts mar decision on stem cells”
San Antonio Express-News
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Adult Stem Cell Bank
Last year the Texas Legislature tasked the Texas Department of State Health Services with establishing criteria for the operation of an autologous adult stem cell bank, meaning a bank that collects, stores and processes adult stem cells for use in treatments on the donor.
TAMR has also monitored this process in order to ensure that the rules established for these banks are based on patient efficacy, safety and standard of patient care. Safe procedures for collection, processing and storage of a patient’s cells must be the first responsibility of a bank.
The draft of rules was approved on June 14 by the Department of State Health Services Council. The proposed rule was then sent to the Health and Human Services Commission for approval to publish in the Texas Register for 30 days for public comment. The only change to the proposed rule (PDF) is the clarification of one definition:
§1.451 (b) was revised to: Autologous Adult Stem Cells are cells taken from a person to be transplanted into that same person.
The Texas Medical Board (TMB) met after the HHSC Council approved the above rule. Several Board members expressed concern about the vagueness of the rules. They felt the criteria/guidelines should be stronger so that physicians could feel confident in the quality and purity of the cells they would be getting from the bank. They also wanted assurances about who would oversee the banks. The legislation authorizing the rule did not give oversight authority to any state entity, so the TMB will submit an inquiry to the U.S. Food and Drug Administration (FDA) seeking clarification of the FDA’s role in oversight.
FDA Report on Houston Stem Cell Bank
A Minnesota bioethecist who testified at a Texas Medical Board hearing earlier this year against the proposed rules for the use of adult stem cells in non-FDA approved therapies filed a complaint with the FDA against Celltex, a Houston company involved in Gov. Rick Perry’s unlicensed adult stem-cell procedure last year. The resulting FDA report identified numerous deficiencies and problems at Celltex, as detailed in the story below.
“FDA report faults Houston stem-cell company”
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