Last April, the FDA inspectedCelltex Therapeutics, which has ties to a controversial stem cell company in South Korea called RNL BIO, after a University of Minnesota bioethics professor wrote the agency to over concerns about patient safety, quality of scientific research supporting the proposed business model and whether both conform to federal and state laws and regulations.
At the time, the agency issued a 483 inspection listing dozens of violations (see here). Now, the FDA has sent a warning letter, citing Celltex for developing a product that is an unlicensed biologic and for violating numerous good manufacturing practices, including a failure to establish and follow written procedures designed to prevent microbiological contamination.
The list of problems is, in fact, quite long and also mentions a failure to validate cell culture processes and conduct sterility investigations, as well as a failure to create a quality-control unit to approve or reject components and containers, among other things. There was also a failure to establish a written record of major equipment cleaning, maintenance and use.
The FDA also noted that standard operating procedures and records that were collected during the April inspection, as well as translated copies provided in correspondence to the agency, apparently related to the RNL Bio facility in Korea and not the Celltex facility in Sugarland, Texas. An oversight? Well, Celltex did provide a translation? (here is the FDA letter).
The inspection was triggered by a letter sent by bioethics professor Leigh Turner amid confusion surrounding the employment status of a former Celltex executive, which triggered scrutiny of the relationship between Celltex and RNL. As we reported previously, in his letter to the FDA, Turner had also written that the two companies planned to bank and administer stem cells, citing various reports as well as an agreement in which RNL was called BioLife Stem Cell at the time (you can read more here).
[UPDATE: Meanwhile, the FDA also issued a warning letter to Texas Applied Biomedical Sciences, an institutional review board that does work for Celltex. In that letter, the FDA notes that an inspection was conducted last April and the agency found, among other things, that the IRB "failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest."
What else? The IRB failed to determine that a pediatric study was in compliance with federal law, prepare and maintain adequate documentation of IRB activities, and also failed to prepare, maintain and follow its written procedures for conducting its initial and continuing review of research, according to the letter.
As a result, "the FDA will withhold approval of all new studies subject to 21 CFR Part 56 and reviewed by the IRB; and no new subjects are to be enrolled in any ongoing studies and approved by the IRB," the letter states (here is the letter). Mildred Joyce Heinrich, who heads the IRB, tells us that "we've responded to the FDA and awaiting a reply." As for Celltex, "they are still a client," she says.] Celltex Therapeutics, by the way, was co-founded by Stan Jones, the same surgeon who treated Texas Governor Rick Perry for back pain with unapproved adult stem cells. Earlier this year, Perry pushed a proposed rule change that enables administration of stem cells to patients as “investigational agents," which is at odds with FDA regulations (back story). Meanwhile, we left a message for Celltex ceo David Eller and will update you accordingly.