Spinoff Breathe Biologics to Lead TSOI’s Stem Cell Therapy Research

Therapy uses JadiCells — mesenchymal stem cells from umbilical cord lining

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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Therapeutic Solutions International (TSOI) has launched a pharmaceutical spin-off — Breathe Biologics — that will take the lead in developing and marketing therapies for chronic obstructive pulmonary disease (COPD), including JadiCell, its investigational stem cell therapy.

TSOI has licensed to Breathe Biologics the investigational new drug (IND) application for its stem cell therapy that it submitted to the U.S. Food and Drug Administration (FDA) asking permission to start testing the therapy in human trials.

“To date regenerative medicine has not been truly applied to the problem of COPD, I am excited to assist Breathe Biologics in accelerating this novel technology to address a significant unmet medical need,” James Veltmeyer, MD, chief medical officer of TSOI, said in a press release.

The FDA assigned the application a number and a new name for the therapy — “Allogeneic Umbilical Cord Mesenchymal Stem Cells, JadiCell; Intravenous injection.”

Lung inflammation and damage to alveoli — the tiny air sacs in the lungs that are responsible for gas exchange — are two hallmarks of COPD, leading to symptoms such as persistent cough, wheezing, and shortness of breath. The regenerative response of alveolar epithelial progenitor cells fails to adequately respond to this damage.

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What are JadiCells?

JadiCells are a type of mesenchymal stem cells (MSCs) derived from the lining of the umbilical cord. MSCs are adult stem cells that retain the ability to generate different cell types in the body. Also, MSCs possess anti-inflammatory, neuroprotective, and regenerative properties that have made them increasingly appealing as potential treatment candidates for some illnesses.

JadiCells have been shown to lessen lung injury and reduce inflammation in a mouse model of emphysema, a severe form of COPD. These cells also outperformed stem cells obtained from other sources, including those derived from bone marrow or fatty tissue, in their ability to do so.

In addition, preclinical data demonstrated that JadiCells may reduce the levels of specific pro-inflammatory proteins, while increasing those of anti-inflammatory markers.

The effects of JadiCell on numerous types of inflammatory disease are profound

Data from a previous COVID-19 trial showed that umbilical cord mesenchymal stem cells prevented, with 100% effectiveness, the death of patients younger than 85 who were on a ventilator in an intensive care unit. In patients older than 85, the survival rate was 91%.

“The effects of JadiCell on numerous types of inflammatory disease are profound,” Veltmeyer said. “In my personal experience, in patients with COVID-19 under Right to Try and Emergency Use IND, the results are nothing short of miraculous.”

Timothy Dixon, president and CEO of TSOI, added: “I look forward to the rapid commercialization of the JadiCell for COPD which we believe will have a significant impact on patients.”