Therapeutic Solutions International Receives IND Number 28508 for Chronic Obstructive Pulmonary Disease Clinical Trial and Enters Binding Discussions with FDA for Initiation of Phase I/II Clinical Trial

Rhea-AI Summary

Therapeutic Solutions International has received FDA Investigational New Drug application #28508 for its JadiCell in treating COPD. The FDA assigned a product name, 'Allogeneic Umbilical Cord Mesenchymal Stem Cells, JadiCell; Intravenous injection,' and discussions are underway regarding the trial details. Dr. James Veltmeyer highlighted promising animal data and previous clinical recoveries. The company is currently conducting a Phase III trial for lung damage due to advanced COVID-19, aiming for impactful treatment options in the COPD space.

Positive

• FDA approval of Investigational New Drug application #28508 for JadiCell.
• Product name assigned for JadiCell, enhancing product recognition.
• Promising preclinical data observed in COPD models.
• Ongoing Phase III trial for lung damage in COVID-19 patients.

Negative

• None.

Phase III Adult Stem Cell Company Continues Expansion into Pulmonary Diseases

OCEANSIDE, Calif.--(BUSINESS WIRE)-- Therapeutic Solutions International announced today receiving Investigational New Drug application number #28508 from the United States Food and Drug Administration for its proposed clinical trial evaluating the JadiCell™ in treatment of COPD.

The FDA also assigned to the Company a Product name for its investigational biologic now known as “Allogeneic Umbilical Cord Mesenchymal Stem Cells, JadiCell; Intravenous injection”. Additionally, the FDA has already entered into binding discussions with the Company regarding details of the clinical trial and subject population.

“COPD is a devastating disease, which in my opinion, is ripe for stem cell intervention,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “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.”

The Company previously reported and filed patents on the therapeutic activity of JadiCell in several models of COPD, as well as the ability of the cell to inhibit several pathological mechanisms associated with the condition.

“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,” said Timothy Dixon, President and CEO of the Company.

Currently the Company is running a Phase III clinical trial to treat lung damage in patients with advanced COVID-19.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220523005584/en/

Timothy G. Dixon

ir@tsoimail.com

Source: Therapeutic Solutions International

FAQ

What FDA approval did Therapeutic Solutions International receive for TSOI?

Therapeutic Solutions International received FDA Investigational New Drug application #28508 for its JadiCell in treating COPD.

What is JadiCell and its significance for COPD treatment?

JadiCell is an allogeneic umbilical cord mesenchymal stem cell therapy proposed for COPD treatment, with promising preclinical data supporting its use.

What ongoing clinical trial is TSOI currently undertaking?

Therapeutic Solutions International is conducting a Phase III trial to treat lung damage in patients with advanced COVID-19.

What are the next steps for TSOI regarding its COPD clinical trial?

TSOI is in binding discussions with the FDA to finalize the details of the clinical trial for JadiCell targeting COPD.