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™”.
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.
- 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
- 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)
- Therapeutic Solutions International Announces Positive Preclinical Results Using JadiCells™ in Animal Model of Chronic Obstructive Pulmonary Failure (COPD) (prnewswire.com)
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Source: Therapeutic Solutions International, Inc.
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