The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges, […]
Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics Read More »
The big news broke Friday that the FDA approved two new gene therapies for sickle cell disease. While the approvals were expected and the actual use of these treatments will be complex on several levels, this is a historic development. 2 FDA-approved gene therapies for sickle cell Friday’s news follows on recent UK approval for
Neil Riordan may be most well-known for running the Panama stem cell clinic called simply enough the Stem Cell Institute, but he also has a U.S. firm Signature Biologics. The Panama clinic sells unproven umbilical cord cells grown in a lab for a host of medical conditions. I’ve had many concerns about it over the
FDA warns Neil Riordan U.S. perinatal firm Signature Biologics Read More »
There has been a steady stream of encouraging data on stem cells for MS. Particularly for certain kinds of MS. A new study adds to this upbeat direction. Good news on stem cells for MS Haematopoietic stem cell transplantation for treatment of relapsing-remitting multiple sclerosis in Sweden: an observational cohort study, Journal of Neurology, Neurosurgery,
Weekly reads: stem cells for MS, Kimera Labs IND, FDA lawsuit Read More »
BrainStorm Cell Therapeutics is developing Nurown, an investigational therapy intended for treating ALS. I recently posted about BrainStorm and its prospects for providing real hope on stem cells for ALS. I see it as a long shot. The ALS community needs real hope, but one challenge is determining how good clinical data have to be to
BrainStorm Cell Therapeutics Hail Mary with FDA on Nurown for ALS Read More »
Retraction Watch has been a great resource for those of us who have been following research misconduct. They widely cover and conduct research on retractions, corrections, and other developments in this space. Unfortunately, there’s been plenty to write about even just within the stem cell and cell therapy arena, which is my primary interest. Think
An important appeals case is pending not just for the defendants Cell Surgical Network, et al., but also for the FDA. It could impact the stem cell field very broadly too. Cell Surgical Network lawsuit status Hopefully, we’ll get a decision before the end of this year. Cell Surgical Network is a large chain of
Goldwater Institute weighs in against FDA on Cell Surgical Network lawsuit appeal Read More »
Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this summer the agency warned Regenative Labs. There have been quite a few letters to others in this
FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity Read More »
It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long. It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several
Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions Read More »
Australian biotech Mesoblast has had a rollercoaster ride working toward FDA approval of its mesenchymal cell therapy product remestemcel-L. They are seeking approval for use in patients with graft-versus-host disease (GvHD). More specifically, it is intended for pediatric patients with steroid-refractory acute graft versus host disease, or SR-aGVHD. This is a serious condition and new treatment
Hoping for approval, Mesoblast says FDA wants new remestemcel-L trial Read More »