Recent notable approvals in regenerative medicine

by Alexey Bersenev on July 25, 2011 · 1 comment

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Today, I’d like to overview some recent notable approvals in cell therapy and regenerative medicine.

1. South Korean company FCB PharmiCell got an approval by Korean FDA (KFDA) for commercial sells of the first stem cell product for non-homologous use – HeartiCellgram:

FCB-Pharmicell is using patients’ own mesenchymal stem cells derived from the pelvic bone marrow cells, and developing a new bio-medicine in the form of a stem cell drug the maximizes the “effect” on myocardial infarction.

The company develop the series of other “stem cell products“.

Strangely, this news was aired by Reuters, but was not released by Korean officials (KFDA or/and company’s web-site). Despite the approval by KFDA and completion of clinical trial, data about therapeutic efficacy of the product remain unclear. Some quotes from Reuters:

“Oh of the Catholic University said the lack of independent expert scrutiny and insufficient testing of the treatment’s effectiveness were disappointing for what could otherwise be seen as an indisputable breakthrough.

“Whether the government has done everything in its obligations to be transparent with the public, when it comes to the effectiveness of the treatment, there is some disappointment about that,” Oh said.”

“This approval means a certification that there are no major problems in terms of safety. What it also means is that the (KFDA) will be watching what the market says about the effectiveness,” Oh said.”

2. Fibrocell Science announces FDA approval for the first personalized aesthetic cell therapy in US. laVív® (azficel-T) is a autologous cell product, based on patient’s skin fibroblasts. This product will be commercially used in adult patients with facial wrinkles.

3. Celsense announced FDA approval for the first use of its cell tracking imaging product in clinical trial.
About Cell Sense reagent:

Cell Sense is a novel perfluorocarbon tracer agent used to safely and efficiently label cells ex vivo without the use of transfection agents. Labeled cells are transplanted into the patient enabling researchers and clinicians to non-invasively track the administration and migration of therapeutic cells using MRI.

This is remarkable approval! Finally we have a chance to track cell after transplant and gain more knowledge about mechanisms of their therapeutic action.

(!) bonus: In a meantime Geron and Advanced Cell Technologies have enrolled and treated the first few patients with their embryonic stem cell-derived products in US.
Watch the first ever injection of embryonic stem cell-based product in the eye of patient with macular degeneration:

RegenMed Digest on Stem Cell Assays is sponsored by Regenerative Medicine Jobs. RegenMed is hiring today! Please visit Regenerative Medicine Jobs for recent position openings.

{ 1 comment… read it below or add one }

thomas ichim July 28, 2011 at 3:00 am

This is a great information site ! thank you for doing this and keeping us updated…i was told Korean company is allogeneic, i guess it is autologous MSC??

Tom Ichim, Medistem


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