Wednesday, July 16, 2014

StemCells, Inc., Says Patient Endangerment Charges Lack Merit

StemCells, Inc., said late today that charges that is endangering patients in clinical trials have no merit and that the company’s primary concern is the safety of its patients.

The Newark, Ca., company was responding to a lawsuit filed earlier this week that alleges the firm is manufacturing human cells in a process that puts “patients at risk of infection or death.”

The suit was filed by Rob Williams, a former senior manager at the publicly traded company. Williams said he was unlawfully fired by StemCells, Inc., after bringing the stem cell quality issues to the attention of senior management.

Earlier today, the California Stem Cell Report asked the company for comment. Ken Stratton, general counsel, responded. Here is the text of his reply.
“As you know, StemCells, Inc. is engaged in the research and development of cell-based therapeutics and is currently sponsoring clinical studies of potential therapies for spinal cord injury, AMD and pediatric neurological disorders as well as conducting pre-clinical studies in Alzheimer’s disease.  The pre-clinical AD studies, but none of the clinical studies, are partly funded by CIRM.
“The Company has reviewed the complaint filed by Mr. Williams, a former employee whose employment was terminated for performance deficiencies, and finds no merit to the allegations. The Company has retained Littler Mendelson as its litigation counsel and intends to defend itself vigorously in court.

“You should know, the elements of manufacturing practices that concerned Mr. Williams were immediately and carefully reviewed by the Company.  The Company’s primary concern has always been, and will continue to be, the safety and tolerability of stem cell transplantation in its clinical trials. Over the years, we have consulted with multiple experts in the field and we believe our processes, procedures and controls, as fully described in our regulatory filings, are appropriate for a company at our early stage of clinical development and comport with applicable guidelines and regulations.  To date, no patients participating in the Company’s clinical studies have experienced any product related safety concerns.

“We hope you find this information helpful.”
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7 comments:

  1. Anonymous12:37 PM

    It may be worth noting that this matter coincides with the departure this past April or May of StemCells, Inc.'s Executive VP of Manufacturing Operations and Regulatory Affairs (Stewart Craig), who took a position at another company (Sangamo).

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  2. Anonymous7:36 AM

    Interesting. The Executive VP of R&D, Eliseo Salinas, arrived full time in 2013 and left in less than a year as well. Just high turnover in biotech or related to Craig and Williams leaving?

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  3. Anonymous9:46 AM

    interesting that 7:36am anonymous mentions 'arrived full time in 2013 and left in less than a year' without mentioning that Mr. Salinas on LinkedIn lists himself as having been an advisor to StemCells, Inc. for 8 months, prior to becoming a 'full time' executive in 2013, and that Mr. Salinas seems to have had at least one other senior position relatively recently of 2 years, as can be seen on LinkedIn. Is 7:36 anonymous 'just accidental partial information and neutral speculation or something else?

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  4. Anonymous9:08 PM

    Certainly seems as if something untoward could be going on at StemCells. Yet what did Mr Williams do to protect the patients and doctors he claims to be so concerned about. Did he ever contact the surgeons involved and warn them directly? Or contact any of the scientists who received cells from his GMP facility while working with the company to see if any of them had problems with the cells? Or was he only really worried about Mr Williams?

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    Replies
    1. Re whether Williams notified some of the persons involved outside of the management of StemCells, Inc., his attorney declines to comment beyond what was filed in court. Obviously Williams was not a happy employee. It is easy to make charges. But frivolous lawsuits also can carry a cost. The real concern here is whether patients have been notified about the lawsuit and StemCells, Inc.'s response. We hope to have more on that soon.

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    2. In case some readers may have missed this item, here is a link to a follow-up on whether patients have been notified. The bottom line is that it is unclear. We are continuing to look into the matter.
      http://californiastemcellreport.blogspot.com/2014/07/cloaking-informed-consent-in-clinical.html

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  5. Anonymous9:44 PM

    If his attorney is worth anything, he should have consulted the scientists who collaborate with the company or received the CIRM grants and found out if they had problems.

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