Celltex News

Celltex clients address FDA during two-day hearing on stem cell regulation

The U.S. Food and Drug Administration (FDA) held its much-anticipated hearing on the regulation of human cells, tissues and cellular and tissue-based products (HCT/Ps) on September 12-13, 2016, where it received public comment from hundreds of individuals, including three clients of Houston-based biotechnology company Celltex Therapeutics Corporation.

Samantha Wilkinson, Sarah Hughes and her mother, Fiona Cunningham, shared personal testimonies of how stem cell therapy, using adult stem cells isolated, extracted and expanded by Celltex, improved their lives. Celltex is registered with the FDA as an HCT/P establishment that multiplies human cells and cellular products. The company operates in a state-of-the-art laboratory compliant with Current Good Manufacturing Practice (cGMP) standards as recommended by the FDA for the manufacturing of biological products.

Wilkinson, who was diagnosed with multiple sclerosis in 1995, went from a wheelchair to a walker, allowing her improved mobility, and Hughes, who has systemic juvenile idiopathic arthritis (SJIA) and dysautonomia, was able to have her feeding tube removed and has since returned to an active lifestyle.

“We are pleased that the panel was able to hear from our clients and hope their testimonies leave a resounding impression of what adult autologous stem cell therapy can do when a person uses his or her own adult stem cells to improve quality of life,” Celltex CEO David Eller says.

Celltex isolates, multiplies and banks adult mesenchymal stem cells (MSCs) for its clients. MSCs act as the body’s natural repair tool, and clinical data from trials all over the world shows there is no known risk of a person’s body rejecting its own stem cells.

Celltex’s unique technology starts with approximately 200,000 MSCs taken from a small sample of fat tissue and, through its proprietary cell extracting, isolating and expanding process, yields hundreds of millions of a client’s MSCs, which are introduced back into the body.
“Not all stem cell therapies are created equal,” Eller says. “At Celltex, our stem cell product is pure in that we isolate the MSCs and then, over the course of up to five weeks, grow the initial population of MSCs to 200 million, which serves as the client’s master bank. When therapy is needed, we thaw 12 million MSCs and culture up to 200 million in 14 days.”

Therapy using Celltex-processed adult stem cells is administered by licensed physicians at Hospital Galenia, a private hospital in Cancún, Mexico. Hospital Galenia operates in accordance with the Federal Commission for Protection against Sanitary Risk, or COFEPRIS, which is considered the regulatory equivalent of the FDA in Mexico.
Video of the two-day hearing is available online (Day 1 and Day 2), and FDA officials will receive additional comments from any citizen, advocate or company through September 27, 2016.

Sarah Hughes before (November 2014, left) and after (May 2016, right) adult stem cell therapy. Hughes was one of three Celltex clients who addressed the FDA at a two-day hearing on the regulation of stem cell therapy.

Post Tags: fight for stem cell therapy, success stories