SVF drug

Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court

us-stem-cell-clinic

In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is …

Groundbreaking defeat for US Stem Cell, fat stem cell clinic industry in federal court Read More »

New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network

Cell-Surgical-Network-Founders

Two new FDA inspection reports called 483s provide fresh insights on a stem cell clinic, the network of clinics that it belongs to, and adverse events in patients. These reports detail issues the FDA found at the stem cell clinic California Stem Cell Treatment Center and its parent chain of clinics, Cell Surgical Network. The …

New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network Read More »

FDA warning points to tougher regulation of fat stem cells & clinics

FDAADF-300x252

Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment …

FDA warning points to tougher regulation of fat stem cells & clinics Read More »

FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US

Gionis-Warning-Letter

The FDA has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions. At one time this clinic was part of the larger Cell Surgical Network (CSN) …

FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US Read More »