TSOI Nets IND Number Ahead of Proposed JadiCell Clinical Trial

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by Steve Bryson, PhD |

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Note: This story was updated June 6, 2022, to note that the U.S. Food and Drug Administration has assigned an Investigational New Drug application (IND) number to Therapeutic Solutions International experimental JadiCell therapy. The FDA has not yet approved the company’s IND application.

The U.S. Food and Drug Administration’s review of JadiCell as a treatment for chronic obstructive pulmonary disorder (COPD) has taken a step forward with the assignment of an Investigational New Drug (IND) application number ahead of a proposed clinical trial to evaluate the therapy.

The company asked the agency for permission in the form of an IND application following TSOI’s announcement that the therapy preserved lung function in mice with inflammation-induced lung damage.

JadiCell is currently being tested in a Phase 3 trial for COVID-19, and TSOI was recently granted an IND for chronic traumatic encephalopathy (CTE), or brain degeneration caused by repeated head trauma.

“COPD is a devastating disease, which in my opinion, is ripe for stem cell intervention,” James Veltmeyer, MD, chief medical officer of TSOI, said in a press release. “Based on the striking animal data in COPD models, as well as clinical recoveries in other pulmonary conditions that I have witnessed, I am eager to begin formal clinical investigations of this cell.”

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With the IND, the FDA assigned the stem cell therapy the new name of “Allogeneic Umbilical Cord Mesenchymal Stem Cells, JadiCell; Intravenous injection.” In addition, the company has already begun discussions with the FDA regarding clinical trial details and participant population.

COPD is marked by lung inflammation and damage to alveoli — the tiny air sacs in the lungs responsible for gas exchange. The precursor cells that line the alveoli, called alveolar epithelial progenitor cells, cannot adequately respond to this damage by generating enough new alveoli.

JadiCells are mesenchymal stem cells (MSCs) — a type of adult stem cell found in several tissues that can give rise to many different cell types. MSCs possess anti-inflammatory, neuroprotective, and regenerative properties that have made them increasingly popular as potential therapeutic avenues for some conditions.

According to TSOI, JadiCells, derived from the lining of the umbilical cord, may outperform other types of stem cells in producing certain therapeutically relevant factors and be stimulated in alternate ways to enhance their regenerative effects.

In a mouse model of emphysema, a severe form of COPD, JadiCells reduced lung injury and surpassed stem cells from other sources, including those from adipose (fatty) tissue or bone marrow, in their ability to do so. Preclinical data also indicated JadiCells may reduce levels of specific pro-inflammatory proteins, while increasing those of anti-inflammatory markers.

Supporting JadiCells’ use in COPD, data from the Phase 3 COVID-19 study demonstrated 100% effectiveness in preventing mortality among patients under the age of 85 who were on a ventilator in the intensive care unit. In patients older than 85, the survival rate was 91%.

“We are thankful to the FDA for rapidly initiating the review of our work and we are confident that through this interaction we will create a trial that is beneficial to patients suffering from this condition for which to date, no curative options exist,” Timothy Dixon, president and CEO of TSOI, said.