Two-year clinical trial, authorized by COFEPRIS, will examine impact of autologous mesenchymal stem cells on rheumatoid arthritis and osteoarthritis -
Houston-based biotechnology company Celltex Therapeutics Corporation announced its authorization to conduct an investigational protocol, a Phase II B Wellness Protocol Clinical Study on Rheumatoid Arthritis and Osteoarthritis (No. 173300ES450822/2017) by the Comisión Federal Para La Protección Contra Riesgos Sanitarios Comisión de Autorización Sanitaria (COFEPRIS), Mexico’s equivalent governmental regulatory body to the United States Food and Drug Administration (FDA). As trial sponsor, Celltex will provide adult autologous adipose tissue-derived mesenchymal stem cells (AdMSCs) cultured and expanded by Celltex’s proprietary stem cell process, which yields adult autologous AdMSCs in quantities never possible for use in therapies for vascular, autoimmune, and degenerative diseases, as well as injuries.
The trial will take place at Hospital Galenia, a private hospital awarded with three international accreditations: Consejo De Salubridad General (Mexico), Joint Commision International, and Accreditation Canada International. The modern facility presents an advanced medical infrastructure with highly-trained physicians in the field of regenerative medicine, responsible for the application of the stem cell therapy under the Wellness Protocol Clinical Study.
The trial’s objective is to measure the quality of life of subjects prior to stem cell therapy, compared to the quality of life after receiving the therapy.
“We are honored to continue our partnership with Hospital Galenia, who we have worked with for over five years to provide life-changing stem cell therapy to clients in need,” said Celltex Chief Executive Officer David Eller. “This trial is an important stride in continuing the advancement of the possibilities of AdMSCs for regenerative medicine breakthroughs in Mexico and in the United States.”
About Celltex Therapeutics Corporation
Celltex uses proprietary technology that isolates, multiplies and banks autologous (one’s own) adult mesenchymal stem cells (MSCs), to be used in regenerative therapy for injuries and chronic pain, as well as many other conditions, including vascular, degenerative, and autoimmune diseases. Celltex is registered with the U.S. Food and Drug Administration (FDA) as an HCT/P establishment that multiplies human cells and cellular products. The Houston-based biotechnology 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. To learn more about Celltex, visit www.celltexbank.com.
About Hospital Galenia
Hospital Galenia is the only highly specialized hospital in the state of Quintana Roo as well as the only hospital in the southeast of Mexico holding the Certificate of Medical Attention Establishments granted by Joint Commission International (JCI), Accreditation Canada International (ACI) and the General Health Council (CSG Mexico). These accreditations assure the fulfillment of international standards. Our medical staff is board-certified or board-eligible. Our physicians have been trained in many of the best medical schools and hospitals in the world. Our medical staff provides services in more than 70 specialties, and currently attracts patients from the United States and Canada. To learn more about Hospital Galenia, visit www.hospitalgalenia.com.
About the Comisión Federal Para La Protección Contra Riesgos Sanitarios Comisión de Autorización Sanitaria (COFEPRIS), United States of Mexico
To protect the population against health risks caused by the use and consumption of goods and services, health supplies, as well as by their exposure to environmental and labor factors, the occurrence of health emergencies and the provision of health services through the regulation, control, and prevention of health risks. To learn more about COFEPRIS, visit www.cofepris.gob.mx.