Celltex IND Approved by FDA to Launch Clinical Trial to Investigate Prophylactic Safety & Efficacy of AdMSCs against COVID-19

Jun 27, 2020 | Coronavirus, COVID-19, Mesenchymal Stem Cells, News, Regenerative Medicine

Celltex IND Approved by FDA to Launch Clinical Trial to Investigate Prophylactic Safety & Efficacy of AdMSCs against COVID-19

Houston-based Celltex received approval from the U.S. Food and Drug Administration (FDA) to proceed with the company’s Investigational New Drug Application (IND 22055) to investigate prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus 2019 (COVID-19). 

The Premise

Celltex Chairman and CEO David G. Eller suggests that throughout the COVID-19 pandemic, the use of Mesenchymal Stem Cells (MSCs) have exhibited potential as a means of treating COVID-19 associated symptoms and complications, and hence the opportunity for what he describes the biotech as the “nation’s leading commercial MSC banking and technology company.”

Review of MSC-based Research & COVID-19

The use of MSCs to combat COVID-19 raises different perspectives and points of view. In a Chinese study, seven COVID-19 patients received intravenous infusions of donor MSCs. The results evidenced overall safety and that their results may improve patient outcomes. Despite that, scientists are not in alignment with the logic behind this method and how well MSCs performed in this pilot study. TrialSite News reported on the FDA approval of Mesoblast’s IND for an MSC-based product. The study was premised on the fact that their investigational product remestemcel-L was successful in a Phase 3 clinical trial for steroid-refractory acute graft versus host disease (aGVHD) in children—a potentially fatally inflammatory condition due to a similar cytokine storm process as seen in COVID-19 acute respiratory distress syndrome. In May, the company reported that the first patients were dosed in the 300-patient randomized placebo-controlled Phase 2/3 trial in the United States of Mesoblast’s allogeneic cellular medicine remestemcel-L.

The University of Miami conducted a Phase 1/2 clinical trial investigating the safety and efficacy of human umbilical cord-derived Mesenchymal Stem Cells (UC-MSC) for treating COVID-19 patients with severe complications of acute lung injury/acute respiratory distress syndrome (ALI/ARDS). The results should be posted soon. The Miami study is led by the renowned Dr. Camillo Ricordi, Chief Academic Officer of the Diabetes Research Institute of the University of Miami and director of the DRI’s Cell Transplant Center. He is a key opinion leader in the field of stem cell research.

A review of Clincialtrials.gov reveals at least 36 MSC-based clinical trials targeting various aspects of COVID-19, but primarily ARDS and other severe conditions. The use of the MSC as a prophylaxis is not as common in these studies.

The Study

This Phase 2 multi-center, randomized, double-blind, placebo-controlled study investigates the safety and prophylactic efficacy of AdMSCs against COVID-19. The sponsor seeks to enroll 200 patients in the trial who have never been infected with SARS-CoV-2, the virus behind the COVID-19 pandemic. 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 the 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 Profile

Celltex uses proprietary technology that isolates, multiplies, and cryopreserves 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.

The Nation’s Leading Commercial MSC Banking Company

Celltex Therapeutics Corporation is a Houston, Texas-based biotechnology company founded in 2011 and a pioneer in autologous MSC technology. Celltex is the nation’s leading 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 and superior grade MSCs for therapeutic use.

Biotech Aspirations

Celltex has dedicated years to researching the 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 (COPD).

Intellectual Property

Celltex’s intellectual property (IP) 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 (ARDS), 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&M University System that includes several patents pending and an A-1 Exosome Patent Application covering composition of matter and method claims in the U.S., Europe, Mexico, and Saudi Arabia.

Ties to Mexican Hospital

Celltex’s headquarters and primary laboratory are located at 2401 Fountain View in Houston, Texas, 77057. It is recognized as the leader 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 modern private hospital with 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 authorized by COFEPRIS, the Mexico equivalent of the U.S. FDA.

Controversy

The company has experienced some controversy in the past. For example, back in 2013, it participated in medical tourism at its Hospital Galenia operation. It initially treated patients in its Sugar Land Texas facilities; however, the company received a cease and desist by the U.S. FDA in 2012. They received a warning letter from the federal authority that the patient-derived cells it harvested and injected into patients were considered drugs under federal law and hence required clinical trials and regulatory approvals. The company was also dinged in its Warning Letter for mishandling cells, failing to keep them in sterile conditions, and mislabeling containers. The company set up the Mexico operation after that; however, the laws in Texas changed, enabling them more flexibility in the Lone Star State. Known as “Charlies Law,” it purportedly offered more flexibility around non-FDA approved stem cell treatments. At the time, Texas’s former first lady was on the board of directors and was actively involved in lobbying for the bill. That a direct to consumer stem cell clinic is beneficial for patients also rings the scientific warning bells.

Other Clinical Trials

Celltex has fully ramped up an FDA-compliant research apparatus and now conducts GcP-based clinical trials in the United States. The company sponsors a Phase 1-2a IND for rheumatoid arthritis and a Phase 2 IND for osteoarthritis with the FDA. Celltex has also recently filed an additional IND application that will investigate allogeneic (donor) MSCs for the treatment of COVID-19-induced symptoms.

Call to Action: Houston-based Celltex received FDA approval to proceed with a clinical trial for AdMSCs as a prophylactic against COVID-19 was notable and hence will go under TrialWatch to monitor the study once it starts.

Source: businesswire

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