Celltex response to recent FDA ruling against US Stem Cell Clinic
See how Celltex has responded to the recent FDA ruling against US Stem Cell Clinic by expressing the importance of how they are different from other stem cell companies due to their commitment of safe practices. Celltex continues to be in compliance with FDA regulations to ensure a safe and effective process for all clients.
Celltex continues to work in compliance with the U.S. FDA while improving the quality of life of countless individuals.
The FDA recently issued a statement against US Stem Cell Clinic in Florida, which orders the clinic to:
“stop manufacturing or distributing any and all stromal vascular fraction (SVF) products, which are adipose (fat) tissue derived stem cell products, until they come into compliance with the law.
The U.S. Department of Justice, on FDA’s behalf, initiated this action against US Stem Cell Clinic LLC and US Stem Cell Inc., and Comella in May 2018, seeking a permanent injunction after they failed to come into compliance with the law, including FDA regulations intended to protect patients from harm. On June 3, 2019, the Court granted the government’s motion for summary judgment after concluding that the defendants adulterated and misbranded their cellular products made from patients’ adipose tissue.”
The statement goes on to address the future of stem cells:
“Stem cell products hold significant potential to improve human health…The FDA is committed to helping advance the safe and effective development of novel stem cell products. We look forward to working with those who share our goal of bringing safe and effective products to market to benefit individuals in need.”
In response to this statement, Celltex has provided the below overview of how we are different from other stem cell companies, such as U.S. Stem Cell, due to our commitment to safety. We look forward to continuing working in compliance with the FDA to improve the quality of life of those in need.
- Our state-of-the-art lab is registered with the FDA as a Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) Lab and as a Biological Drug Lab – and as such, we’ve made sure the laboratory meets or exceeds Current Good Manufacturing Practice (cGMP) standards. All of Celltex’s operations are compliant with FDA guidelines and procedures, and all of our clients’ stem cells are banked (cryogenically stored) in the United States.
- Celltex’s lab includes separate manufacturing, Quality Control and Quality Assurance teams to ensure the quality, identity, strength and purity of each individual client’s stem cells throughout the entire banking and manufacturing process.
- The Celltex process does not involve donors. An individual has his or her own mesenchymal stem cells (MSCs) harvested from their own adipose tissue, and their own MSCs are then multiplied and banked for future therapy for use by that individual only.
- Celltex does not offer same-day therapy and works closely with potential clients to ensure MSC banking and therapy is the right fit for their individual needs. To date, Celltex has not received any reporting of an adverse reaction.
- Our process ensures the integrity and stability of one’s cells in quantities never before possible – FAR exceeding what’s possible in a same-day therapy. Once a person’s MSCs have been isolated, the Celltex process can establish a master cell bank for that individual in approximately eight weeks. The MSCs are cryogenically banked at -300 degrees Fahrenheit until the client is ready to receive therapy through our certified partner. At that time, Celltex’s process enables therapeutic doses in the hundreds of millions of stem cells.
- The Celltex process is not for everyone. MSCs can be used to improve client’s quality of life and as therapy for a range of degenerative, autoimmune, neurological and vascular conditions. When a client expresses interest, Celltex conducts a thorough medical evaluation of the client’s individual case to determine if stem cell therapy will help achieve their health and wellness goals.
Celltex is in compliance with regulations established by the FDA and until stem cell therapy is legalized in the U.S., to meet the immediate needs of our clients, Celltex will continue to work with established, accredited hospitals in Mexico. Where licensed physicians and specialists make it possible for Celltex clients to receive their own MSCs for therapeutic purposes and improve their quality of life today.
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