Patent Request Filed for JadiCells, Potential COPD Stem Cell Therapy
Therapeutic Solutions International has filed a patent covering the therapeutic use of JadiCells — a type of mesenchymal stem cell derived from cells lining the umbilical cord — and its various combinations in treating chronic obstructive pulmonary disease (COPD).
The patent application is supported by new data indicating that JadiCells work better than stem cells obtained from other sources, such as the bone marrow or fatty tissue, in reducing lung injury in an animal model of COPD, the company reported in a press release.
In the model, animals are treated with a protein called elastase to induce emphysema, a severe form of COPD in which the tiny air sacs of the lungs become damaged, causing shortness of breath. This resembles in part what happens in people with the disease.
Findings also showed that JadiCells may modulate the immune system’s inflammatory response in the lungs by decreasing the levels of an inflammatory protein called TLR4, and increasing the levels of an anti-inflammatory protein called MerTK.
“The potent anti-inflammatory and regenerative effects of the JadiCells have been demonstrated in a variety of in vitro and in vivo settings. Given the inflammatory nature of COPD, as well as previous studies showing potential of regenerative approaches in this condition, we examined the potential of these cells to treat an established animal model of COPD,” said James Veltmeyer, MD, chief medical officer of Therapeutic Solutions.
“Based on the preliminary positive results, as well as what appears to be a unique mechanism of action, we are in the process of continuing our exploration of JadiCells in COPD, which we believe will be the basis for another IND application,” Veltmeyer added.
An investigational new drug (IND) application is a formal request made by therapy developers to regulatory authorities for permission to test an experimental therapy in human trials.
Mesenchymal stem cells are adult stem cells that are present in various tissues, including the umbilical cord, bone marrow, and fatty tissue. They can self-renew by dividing and are multipotent, meaning they can give rise to several cell types making up different tissues, including bones, muscles, and fat.
According to the company, JadiCells are thought to produce higher amounts of certain therapeutic factors compared with other stem cells, and may be stimulated in different ways such that their ability to regenerate tissues is enhanced.
These stem cells also have the potential to be used in a range of diseases. In a Phase 1/2 clinical trial (NCT04355728), JadiCells were found to be safe and show early evidence of effectiveness in COVID-19 patients who were on ventilation at a hospital’s intensive care unit.
Specifically, JadiCells improved survival in 12 treated patients compared with 12 others given a control solution that contained no stem cells. In JadiCell-treated group, patients younger than 85 had a 100% survival rate, and this rate in those older than 85 was 91%.
Treatment with JadiCells was also associated with a significantly shorter recovery time, and significantly fewer severe adverse events.
The U.S. Food and Drug Administration subsequently cleared the company to start a pivotal Phase 3 clinical trial in people with COVID-19 and associated lung failure.
“We are aiming to concurrently capture as much intellectual property as we can while elucidating in as rapid a manner as possible what indications our JadiCells have the best potential for accelerated development,” said Famela Ramos, vice president of business development at Therapeutic Solutions.