JadiCell (allogeneic umbilical cord mesenchymal stem cells) / Therapeutic Solutions - LARVOL DELTA

Therapeutic Solutions International Announces Landmark Finding Regarding Mechanism of Action of its JadiCell Stem Cell Product (Businesswire) - "Therapeutic Solutions International, Inc. (TSOI), announced today results of ongoing experiments demonstrating that the healing effects of JadiCells appear to be mediated by a biological mechanism involving interplay between two types of immunological cells found in the body. Using the inflammation-induced lung injury model, the Company found that JadiCell administration caused an increase in monocytes expressing the cytokine interleukin-35 as well as T cells expressing an anti-inflammatory molecule called TGF-beta."

Clinical • CNS Disorders • Respiratory Diseases

Therapeutic Solutions International Subsidiary Allogen Biologics Inc. Successfully Manufactures JadiCell Master Cell Bank to Provide Cells for Right to Try Use and Phase III ARDS Clinical Trial (Businesswire) - "Therapeutic Solutions International, Inc. (TSOI), reported today successfully generation of a quality control tested Master Cell Bank comprised of its JadiCell universal donor stem cell product. Prior to this, the Company relied on third party manufacturing, which carried significantly more costs as well as potential regulatory uncertainty. The recently generated cells possessed both functional and phenotypic characteristics that the FDA has agreed to in its clearance of the Company to conduct a Phase III clinical trial."

Clinical • Novel Coronavirus Disease • Respiratory Diseases

Therapeutic Solutions International Files for Orphan Drug Designation Use of JadiCell Adult Stem Cells for Treatment of Frontotemporal Dementia (Businesswire) - "Therapeutic Solutions International, Inc...announced today new data and filing with the FDA for Orphan Drug Designation of its JadiCell adult stem cell in the treatment of Frontotemporal Dementia. This neurodegenerative disease is the leading cause of dementia in patients under 60 years old and to date no therapies have been shown to reduce its progression."

Orphan drug • CNS Disorders • Dementia

Therapeutic Solutions International Launches Subsidiary Company to Commercialize Clinical Data and IND for Treatment of Chronic Traumatic Encephalopathy (CTE) with JadiCell Universal Adult Stem Cells (Businesswire) - "Therapeutic Solutions International (TSOI) announced the creation of CTE Biologics, Inc. as a subsidiary company dedicated to commercializing the JadiCell adult stem cell platform for treatment of chronic traumatic encephalopathy."

Commercial • CNS Disorders • Epilepsy

Therapeutic Solutions International Files to Initiate Phase III Clinical Trial for Acute Respiratory Distress Syndrome (ARDS) Leveraging Positive COVID-19 Data with JadiCell Stem Cell Therapy (Businesswire) - "Therapeutic Solutions International (TSOI) announced today filing of a new Phase III clinical trial application with the FDA for use of its JadiCell adult stem cells in treatment of acute respiratory distress syndrome (ARDS). This investigational drug application (IND) is based on the Company’s existing data and experiences associated with its Phase III clinical trial in the area of COVID-19 associated ARDS."

IND • Acute Respiratory Distress Syndrome • Respiratory Diseases

Therapeutic Solutions International Advances Chronic Obstructive Pulmonary Disease Program by Identifying Novel B Regulatory Cell Mechanism of Action for JadiCell Universal Donor Adult Stem Cell (Businesswire) - "Therapeutic Solutions International (TSOI) announced today new data and filing of a patent covering the discovery that JadiCell therapeutic activity in a model of Chronic Obstructive Pulmonary Disease (COPD) can be transferred to naïve animals by a specialized type of B cell....In addition to the patent licensed from JadiCell, LLC (#9,803,176 B2), for respiratory indications, Therapeutic Solutions International has several patent applications pending and published covering the whole family of umbilical cord mesenchymal stem cells, to which JadiCell belongs to, for treatment of COPD, as well as means of selecting for cells with enhanced activity."

Patent • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

"$TSOI #USA is at a ‘crossroads’ as #CovidIsNotOver kills 2,600 a week and new #OmicronVariant bloom JADICELLS QUADRAMUNE are need of the hour! $MULN $TSLA $MASN $GMER $AAPL $BOMO $HUDI $AMZN $WLAN $SNTG $DVLP $ICNM $CGRA $PLPL $SONN $DOGE PPS to $2! $PHIl to 10c @exosome @US_FDA" (@rajupenu)

Novel Coronavirus Disease

Therapeutic Solutions International Announces Successful Treatment of Epilepsy in Animal Model and Complete Cessation of Seizures in Treatment Resistant Patient (Businesswire) - "herapeutic Solutions International (TSOI) announced today successful administration of JadiCells into a treatment resistant epilepsy patient resulting in a profound recovery. The patient was treated under the Right to Try Act as a result of preclinical data demonstrating significant advantage of JadiCells™ compared to standard umbilical cord mesenchymal stem cells in the pilocarpine-induced animal model."

Clinical • CNS Disorders • Epilepsy

"$TSOI @Biorasi CRO conducting Phase 3 trial in #India with JADICELLS™️ is the key to unlock the regeneration of #lung #lungcancer #lungfibrosis @exosome @TSOIsupplement @famelaramos2020 @DrVeltmeyer @CamilloRicordi @FrancoMarincola @US_FDA @FDAMedWatch @TheLaurenChen @ljin18" (@rajupenu)

P3 data • Fibrosis • Idiopathic Pulmonary Fibrosis • Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor

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 (Businesswire) - "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....Additionally, the FDA has already entered into binding discussions with the Company regarding details of the clinical trial and subject population....'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,'....Currently the Company is running a Phase III clinical trial to treat lung damage in patients with advanced COVID-19."

FDA event • IND • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Therapeutic Solutions International Files Investigational New Drug Application for Treatment of Chronic Obstructive Pulmonary Disease (COPD) Using JadiCell Universal Donor Adult Stem Cells (BioSpace) - "Phase III Stem Cell Company Expands Clinical Programs to Address $10 Billion COPD Market....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'..."

IND • Chronic Obstructive Pulmonary Disease

"$TSOI JADICELLS™️ treats #pneumonoultramicroscopicsilicovolcanoconiosis a #lung #disease caused by #silica #dust, sometimes cited as one of the longest words in the English language. Only FDA Ph 3 clinical trial #mesenchymal stemcell therapy @drgauravchandra @EricTopol @exosome" (@rajupenu)

Clinical

Therapeutic Solutions International Announces Positive Preclinical Results Using JadiCells in Animal Model of Chronic Obstructive Pulmonary Failure (COPD) (PRNewswire) - "Therapeutic Solutions International, Inc...announced new data and a patent filing covering the use of JadiCells™ and various therapeutic combinations for the treatment of COPD....Superior reduction in lung damage was observed in animals receiving JadiCells™ as compared to other clinically used stem cells such as adipose and bone marrow derived mesenchymal stem cells. In addition, JadiCell™ treated animals possessed significantly decreased expression of the inflammatory proteins toll like receptor 4 and increased expression of the anti-inflammatory protein MerTK....'Based on the preliminary positive results, as well as what appears to be a unique mechanism of action, we are in the process of continuing our exploration of JadiCells in COPD, which we believe will be the basis for another IND application.'"

Patent • Preclinical • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

"$TSOI shooting up to over ¢10 today! JADICELLS™️to #SARSCoV2 patients! @aaaamhim @TamiTrader @US_proptrader @SmallCapsDaily @prasant56069147 @FPSwatchlist @JeffTheOmega1 @Troy_Goodale @ethanFlare @groman100 @susanfoofoo @jfigueredo @MarcJacksonLA @otcdynamics @StckPro @FrnkTss" (@rajupenu)

Clinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"$TSOI PPS to $10!Train is just about to leave nearing FDA Ph.3 initiation approval on JADICELL™️ @DoctorAmitPatel @StimulusPKG822 @Bluew3312 @GavBlaxberg @MaxTheComrade @Aktrader56 @WOLF_Financial @Stockminds009 @Greenbuud9 @US_FDA @NIH @UofMiami @CampbellNeuros1 @TSOIsupplement" (@rajupenu)

FDA event

"@DoctorAmitPatel please what are the next steps for #jadicell ?" (@photonemperor1)

ImmCelz Stem Cell Component Demonstrated Efficacious in FDA Double Blind Placebo Controlled Clinical Trial of Advanced COVID-19 Patients (PRNewswire) - P1/2, N=24; NCT04355728; "...intravenous administration of umbilical cord derived stem cells, termed 'JadiCells' results in a significant survival improvement in COVID-19 patients....At 28 days 91% of JadiCell™ treated patients survived whereas only 42% of patients in the placebo group survived. There were no adverse effects associated with JadiCell™ administration....'The data reported today strongly supports the safety and potency of the JadiCell™, which also supports the validity of ImmCelz® which is 'powered by JadiCell™.'"

P1/2 data • Infectious Disease • Novel Coronavirus Disease

JadiCell Stem Cells Licensed by Therapeutic Solutions International for Brain Injury Significantly Increased Survival of COVID-19 Patients in Double Blind FDA Clinical Trial (PRNewswire) - "P1/2, N=24; NCT04355728; "The Phase 1/2 double blind, placebo-controlled trial treated 12 advanced COVID-19 patients with 100 million JadiCells™ intravenously at days 0 and 3, and 12 patients received placebo control. At 28 days 91% of JadiCell™ treated patients survived whereas only 42% of patients in the placebo group survived. There were no adverse effects associated with JadiCell™ administration.....'Not only do these data support safety of intravenous administration, but also attest to the potent anti-inflammatory and regenerative effects of this unique stem cell population.'"

P1/2 data • Infectious Disease • Novel Coronavirus Disease