Policy & Regulation
Celltex Therapeutics Receives FDA Approval for Phase II Clinical Trial Using Mesenchymal Stem Cells as a Prophylactic Against COVID-19
26 June 2020 - - Houston, Texas-based biotechnology company Celltex has received approval from the US Food and Drug Administration to proceed with the company's Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19), the company said.

This is a Phase 2 multi-center, randomized, double-blind, placebo-controlled study that will evaluate the safety and prophylactic efficacy of AdMSCs against COVID-19.

Celltex will enroll 200 patients in the study (https: //www.clinicaltrials.gov/ct2/show/NCT04428801) who have never been infected by COVID-19.

One hundred patients will receive intravenous infusions of autologous AdMSCs while 100 will receive placebo treatments.

The primary objective of the study is to evaluate overall safety of AdMSCs, and the secondary objective is to demonstrate the efficacy of AdMSCs as a prophylactic medicine for those at a high risk of contracting the virus.

Celltex Therapeutics Corp. is a Houston, Texas-based biotechnology company founded in 2011 and a pioneer in autologous MSC technology.

Celltex is a commercial MSC banking company and focuses on spearheading breakthroughs in regenerative medicine using autologous MSCs.

The company uses its own proprietary technology in its Houston-based, cGMP laboratory to isolate, cryopreserve and grow hundreds of millions of autologous, superior grade MSCs for therapeutic use.

Celltex has dedicated years to researching safety and efficacy from the use of MSCs for those suffering from injuries, pain and maladies associated with autoimmune, vascular and other debilitating diseases, including inflammatory lung conditions, pneumonia and chronic obstructive pulmonary disease.

Celltex's intellectual property portfolio encompasses over 1,500 clients, who have received over 9,000 MSC therapies for various diseases without incurring any adverse events.

These diseases include acute respiratory distress syndrome, inflammatory lung disease, influenza and other viruses similar to coronavirus (COVID-19). Celltex's cGMP manufacturing processes provide Celltex with unique commercial advantages.

The company has also acquired the intellectual property rights and holds an Exclusive License Agreement with Texas A and M University System that includes several patents pending and an A-1 Exosome Patent Application covering composition of matter and methods claims in the US, Europe, Mexico and Saudi Arabia.

Celltex's headquarters and primary laboratory are located at 2401 Fountain View in Houston, Texas 77057. It is in commercial MSC banking both in the United States, and in Mexico.

The headquarters and laboratory operations of its wholly-owned Mexican subsidiary are located in Hospital Galenia, in Cancún, Quintana Roo, Mexico.

Hospital Galenia is a private modern hospital that holds three award accreditations from the field of health: two International and one National, with advanced medical technology, a vanguard infrastructure and a highly trained and well-accredited team.

In Mexico, the company sponsors a Phase III Protocol/Clinical Trial for COVID-19 with Hospital Juarez, a government hospital, to treat COVID-19 symptoms, such as respiratory complications, pulmonary complications and pneumonia.

It also sponsors an ongoing 400-person Phase IIb clinical trial (rheumatoid arthritis and osteoarthritis) at Hospital Galenia in Cancún.

Both trials have been authorised by COFEPRIS, the Mexico equivalent of the US FDA.

Celltex uses proprietary technology that isolates, multiplies and cryopreserves autologous (one's own) adult mesenchymal stem cells, 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 US Food and Drug Administration as an HCT/P establishment that multiplies human cells and cellular products.

The Houston-based biotechnology company operates in a laboratory compliant with Current Good Manufacturing Practice standards as recommended by the FDA for the manufacturing of biological products.


Related Headlines