Followers | 88 |
Posts | 8196 |
Boards Moderated | 0 |
Alias Born | 06/17/2013 |
![](https://investorshub.advfn.com/uicon/404071.png?cb=1506674193)
Saturday, September 24, 2022 2:53:06 PM
(and bringing us all up to date)
https://firstwordpharma.com/story/5560979
Therapeutic Solutions International Announces Launching of Phase III Clinical Trial for Treating COVID-19 Lung Damage Using its JadiCell Universal Donor Stem Cell Drug
Ref: Business Wire
Published: May 02, 2022
Landmark Study Aimed to Support FDA Registration of First Cell Therapy with Dual Anti-inflammatory and Lung Healing Mechanism of Action
OCEANSIDE, Calif.--(BUSINESS WIRE)-- Therapeutic Solutions International announced today the launching of a double-blind, randomized, placebo controlled, multi-center, multi-nation, clinical trial of 128 patients with COVID-19 associated lung failure.
The study will be comprised of two groups, JadiCell™ treatment group and control group. The primary endpoint of the study is comparing the proportion of patients alive and free of respiratory failure at Day 60 after treatment with JadiCells as compared to placebo.
The Company has licensed the issued patent covering composition of matter for JadiCell and FDA Right of Reference1,2, has identified and filed patents on novel mechanisms of action of JadiCell related to lung preservation and regeneration3,4,5, and acquired the FDA cleared IND and associated data package, which was the basis for Phase III clearance6, and has contracted Biorasi, a global, full-service CRO, to launch and run the clinical trial.
"Cell therapy is one of the most promising and demanding forms of medical intervention," said Chris O'Brien, CEO of Biorasi. "In contrast to traditional medicines, products such as JadiCell are living therapeutics, which require a very detail-oriented approach to their administration as well as patient follow-up. We are honored to partner with TSOI for this landmark 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, the JadiCell was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85 in a double-blind, 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%7.
"The launch of this clinical trial is a historical step for Therapeutic Solutions International, but also to patients with degenerative lung diseases in general," said Dr. James Veltmeyer, Principal Investigator of the Clinical Trial and Chief Medical Officer of TSOI. "Given the extremely positive effects that we have seen in the previously published double blind clinical trial, as well as our own Right to Try case reports, I am extremely enthusiastic to begin this last step before obtaining marketing approval by the FDA."
"Having worked with the JadiCell for several years now, I can state with full confidence that this is by far the most potent stem cell that we have seen to date," stated Dr. Thomas Ichim, Board Member of the Company. "Given its unparalleled ability to stimulate angiogenesis, suppress lung inflammation, augment healing of scar tissue in the lung, and stimulate endogenous lung stem cells, I have high confidence in the rapid success of our clinical trial."
"Having a second-to-none track record of rapid patient recruitment in advanced therapeutics across a variety of indications, we are enthusiastic to work with Biorasi initially to provide the basis for marketing approval for COVID-19 and subsequently to address other unmet medical needs in pulmonary medicine such as chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis," said Timothy Dixon, President, and CEO of the Company.
Recent TSOI News
- Form 8-K - Current report • Edgar (US Regulatory) • 07/31/2024 08:44:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/15/2024 06:14:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 07:42:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/12/2024 07:38:57 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/09/2024 08:44:08 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/09/2024 08:39:55 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 05/31/2024 08:51:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/31/2024 04:47:07 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/31/2024 12:46:43 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/31/2024 12:44:01 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/30/2024 06:46:26 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/15/2024 04:01:05 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/06/2024 10:03:21 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 07:15:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/26/2024 07:12:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/21/2024 10:25:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/20/2024 11:16:15 AM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/08/2024 05:15:25 AM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 02/06/2024 11:34:40 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/22/2024 08:42:55 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 01/17/2024 11:15:01 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 01/04/2024 09:03:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/22/2023 07:44:34 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2023 05:39:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 10/16/2023 11:17:29 PM
HealthLynked Corp. Announces Second Quarter and First Half 2024 Results: Continued Cost Reductions Set the Stage for Strategic Shift to App-Based Technology Services • HLYK • Aug 16, 2024 8:00 AM
PickleJar Announces Official Name Change and New Ticker Symbol • NREG • Aug 15, 2024 2:23 PM
VAYK's Q2 Profit Added to Accumulated Net Profit of Over $2.2 Million In 18 Months • VAYK • Aug 15, 2024 9:07 AM
Swifty Global Reports Strong Q2 Performance and Prepares for Major Exchange Uplisting • DRCR • Aug 15, 2024 9:04 AM
Mayback's Global Entertainment Signs Global Distribution Agreement with Children's Media Studio • AHRO • Aug 15, 2024 8:45 AM
POET Technologies Reports Second Quarter 2024 Financial Results • POET • Aug 15, 2024 8:04 AM