Cell therapy weekly: StemGenex receives warning letter from FDA over unapproved cell therapy and facility with “significant violations”
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This week in cell therapy: HemaCare supplies starting materials for three FDA approved cell therapies and Mesoblast defends stem cell-based therapy for heart failure.
The news highlights:
StemGenex warned over product and manufacturing conditions
HemaCare to supply starting materials for all three FDA-approved cell-based immunotherapies
Mesoblast defends stem cell-based therapy for heart failure
StemGenex warned over product and manufacturing conditions
StemGenex Biologic Laboratories LLC (CA, USA) has received a warning from the FDA over marketing of a ‘stem cell’ product that hasn’t received FDA approval as well as “significant deviations” from good manufacturing practice (GMP) at their manufacturing facility. FDA investigators found StemGenex were illegally marketing an adipose-derived product without a biologics license or an investigational new drug application. They also found “unvalidated manufacturing processes, an uncontrolled environment, lack of control over the components used in production, and the lack of sufficient and validated product testing” at their manufacturing facility.
“…we continue to see bad actors exploit the scientific promise of this field to mislead vulnerable patients into believing they’re being given safe, effective treatments…this is putting patients’ health at risk. It’s also putting at risk the long-term viability of the industry and of effective products, when other operators are misleading consumers by marketing unproven therapies using claims of safety and benefit,” said FDA Commissioner Scott Gottlieb. “We’ll continue to take enforcement actions against companies that abuse the trust of patients and endanger their health with uncontrolled manufacturing conditions or by promoting so-called ‘treatments’ that haven’t been proven safe or effective for any use.”
HemaCare to supply starting materials for all three FDA-approved cell-based immunotherapies
HemaCare Corporation (CA, USA) has announced they are supplying leukapheresis process development material for 100% of the current FDA-approved immunocellular therapies, Kymriah® (Novartis; Switzerland), Yescarta® (Kite, a Gilead Company; CA, USA), and Provenge® (Dendreon; WA, USA). When HemaCare relocate to a larger facility at the end of 2018, they will expand their onsite GMP facilities and bioprocessing capabilities.
“As an esteemed cell therapy partner, HemaCare is proud to collaborate with companies on the frontier of regenerative medicine, and our upcoming GMP facility and service expansion highlight our continued commitment to aid in the development of next-generation personalized therapies. Delivering high-quality starting material for cell therapies is a priority, as it directly relates to the quality and efficacy of the final cell-based product” said Lou Juliano, Senior Vice President, Global Sales and Business Development at HemaCare.
Mesoblast defends stem cell-based therapy for heart failure
A phase II trial of Mesoblast’s allogeneic cell therapy candidate MPC-150-IM has shown it was unable to reduce the reliance of heart failure patients on a left ventricular assist device (LVAD) when administered during implantation. However, a subgroup of the 159 patient cohort was able to be weaned off the device temporality, and there was a 76% reduction in major gastrointestinal bleeds with a 65% drop in bleed-related hospitalizations in patients that received the therapy. Gastrointestinal bleeds are “a major cause of morbidity and increased cost” associated with LVADs, according to Mesoblast.
Mesoblast Chief Executive Silviu Itescu commented: “We are very pleased by the results of this independently conducted trial. The clinically meaningful outcome achieved in these very high-risk patients provides a potential pathway to bring our heart failure product candidate MPC-150-IM to market sooner for these patients in great need.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.