Therapeutic Solutions International Files Investigational New Drug Application for Treatment of Chronic Obstructive Pulmonary Disease (COPD) Using JadiCell™ Universal Donor Adult Stem Cells

Rhea-AI Summary

Therapeutic Solutions International has filed an Investigational New Drug (IND) application with the FDA to treat 10 patients with advanced COPD using its stem cell product, JadiCell™. The company is also developing JadiCell for COVID-19 and Chronic Traumatic Encephalopathy (CTE). Previous studies indicate JadiCell's effectiveness, including a 100% survival rate in COVID-19 patients under 85. The CEO expressed gratitude for the scientific team's efforts leading to this clinical trial application, marking a significant milestone in the company's research and development efforts.

Positive

• Filed IND application for advanced COPD treatment, potentially entering a $10 billion market.
• Demonstrated efficacy of JadiCell in previous studies, with a 100% survival rate in COVID-19 patients under 85.
• Expansion of clinical programs enhances company's market position.

Negative

• None.

Phase III Stem Cell Company Expands Clinical Programs to Address $10 Billion COPD Market

OCEANSIDE, Calif.--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. announced today filing of an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) seeking permission to treat 10 patients with advanced COPD using its universal donor adult stem cell product termed “JadiCell™”.

The Company is currently developing JadiCell as a treatment for COVID-19, for which a Phase III clinical trial has been initiated, as well as for Chronic Traumatic Encephalopathy (CTE), for which the Company has been granted an IND by the U.S. FDA.

“The pain and suffering caused by COPD is very difficult to overstate” said Dr. James Veltmeyer, Chief Medical Officer of the Company, and Principal Investigator of the COPD clinical trial. “Having personally seen tremendous benefits of JadiCells in respiratory patients that I have treated under the Right to Try Act, I am excited to validate the therapeutic properties of these cells in a scientific and controlled clinical trial.”

In previous studies the Company has demonstrated the superior activity of JadiCell to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, in a peer-reviewed publication, the JadiCell was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85. The published study was a report on an FDA double-blinded, randomized, placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%¹.

“Previously we have published on the ability of a patient’s own fat stem cells to reduce symptoms of COPD². JadiCells appear more potent than fat stem cells and do not require the painful and potentially dangerous liposuction procedure” said Dr. Thomas Ichim, Board Member of the Company. “Based on basic science, I am confident that our Phase I study will produce game-changing results.”

“I truly am grateful for our scientific team and collaborators that have made filing of this IND a reality” said Timothy Dixon, President, and CEO of the Company. “Back in August 2021 we announced our initiation of this program³, which today has culminated in what we consider a very exciting clinical trial application. We look forward to adding this pulmonary indication to our existing COVID-19 pivotal trial.”

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com.

1. Umbilical cord mesenchymal stem cells for COVID‐19 acute respiratory distress syndrome: A double‐blind, phase 1/2a, randomized controlled trial - Lanzoni - 2021 - STEM CELLS Translational Medicine - Wiley Online Library
2. Autologous Stromal Vascular Fraction in the Intravenous Treatment of End-Stage Chronic Obstructive Pulmonary Disease: A Phase I Trial of Safety and Tolerability - PubMed (nih.gov)
3. Therapeutic Solutions International Announces Positive Preclinical Results Using JadiCells™ in Animal Model of Chronic Obstructive Pulmonary Failure (COPD) (prnewswire.com)

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20220509005529/en/

Timothy G. Dixon

ir@tsoimail.com

Source: Therapeutic Solutions International, Inc.

FAQ

What is the significance of the IND application filed by TSOI for COPD?

The IND application allows TSOI to initiate clinical trials for treating advanced COPD, targeting a significant market valued at $10 billion.

What is JadiCell™ and its relevance to TSOI?

JadiCell™ is an adult stem cell product developed by TSOI, showing promise in treating conditions like COPD and COVID-19, with previous studies indicating strong efficacy.

How did TSOI perform in their previous studies with JadiCell?

Studies showed a 100% survival rate for COVID-19 patients under 85, positioning JadiCell as a potentially effective treatment.

What other diseases is TSOI targeting with JadiCell?

In addition to COPD, TSOI is developing JadiCell for COVID-19 and Chronic Traumatic Encephalopathy (CTE).

What does the filing of the IND application indicate about TSOI's clinical development?

The filing indicates TSOI's commitment to advancing its clinical programs and potentially validating the therapeutic properties of JadiCell in a controlled trial.