Therapeutic Solutions International Selects Premier Regenerative Medicine CRO Biorasi to Initiate and Run Phase III FDA Registration Clinical Trial for JadiCell™ Universal Donor Adult Stem Cell Product – Yahoo Finance

Company Aims to be "First to Market" Utilizing Stem Cells to Treat and Repair COVID-19 Injured Lungs
OCEANSIDE, Calif., March 28, 2022–(BUSINESS WIRE)–Therapeutic Solutions International announced today its Board of Directors has selected Biorasi as the contract research organization (CRO) to run its Pivotal FDA Registration Clinical Trial assessing efficacy of its JadiCell™ Adult Stem Cell Product in patients with advanced COVID-19.
The clinical trial was cleared by the FDA as a continuation of its previous clinical trial which treated the most severe cases of COVID-19 with stem cell infusions. The unprecedented results allowed for 100% patient survival at one month in subjects treated who were less than 85 years old, and 91% survival in subjects of all ages, compared to 42% survival in the control group1.
"The family of mesenchymal stem cells in general possess dual anti-inflammatory and regenerative properties, which make them a promising therapeutic for lung conditions. Based on published, and our independent studies, the JadiCell appears to be superior to other stem cells both in suppressing cytokine storm and activating endogenous pulmonary repair mechanisms," said Dr. Thomas Ichim, Board Member of TSOI. "Having advanced to the pivotal trial stage of the drug development process we are proud to work with an organization that in our opinion is second to none in terms of quality, expertise and rapid execution".
JadiCells™ have been shown to possess therapeutic activity in animal models of pulmonary fibrosis and COPD. The Company plans to concurrently develop additional pulmonary indications in addition to COVID-19.
"We are enthusiastic to leverage our expertise in the area of cell therapy and COVID-19 with Therapeutic Solutions International," said Marc M. Gas, PhD, Associate Director, Program Development, Biorasi LLC. "Having performed numerous registration trials, we are unique in accelerating trial recruitment and being responsive to situations as they arise in real-time. We look forward to working with Timothy Dixon and his team in addressing this fundamentally unmet medical need."
"Having run stem cell clinical trials, we understand that these types of investigations are characterized by numerous subtleties and peculiarities. We fully appreciate the strengths of Biorasi and are eager to initiate this collaboration, which if successful will result in the first stem cell drug for lung regeneration," said Timothy Dixon, President, and CEO of TSOI. "Because of Biorasi we have been able to expand upon the original multi-site USA trial into a multi-nation trial and have added India as one of two countries with the other likely to be selected from Latin America," added Mr. Dixon.
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 https://therapeuticsolutionsint.com, and our public forum is https://forum.therapeuticsolutionsint.com.
About Biorasi, LLC
Our passion is finding efficient, timely and quality solutions for our partners’ most challenging programs. The process of disruption that we began long ago is still ongoing — we are never finished. Today, we are still a nontraditional, unconventional CRO that proudly claims to be the fastest, most responsive global CRO in the industry. The Company's corporate website is https://biorasi.com
1. Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial
View source version on businesswire.com: https://www.businesswire.com/news/home/20220328005440/en/
Contacts
Timothy G. Dixon ir@tsoimail.com
Related Quotes
The Food and Drug Administration cast doubt on Amylyx Pharmaceuticals' ALS treatment Monday, leading shares to plummet.
The not-so-great side effects of Moderna's flu vaccine candidate could have greater implications.
Wednesday is going to be a very big day for folks with neurodegenerative disorders and a clinical-stage biopharmaceutical company called Amylyx Pharmaceuticals (NASDAQ: AMLX). On March 30, the FDA is meeting with independent neurologists to discuss the company's experimental treatment for amyotrophic lateral sclerosis (ALS). Each year, around 6,000 American adults are diagnosed with ALS after complaining about muscle weakness.
Pfizer Inc. on Tuesday said a second Phase 3 study of its recently acquired investigational drug etrasimod met the main endpoints in the treatment of moderately to severely active ulcerative colitis, a chronic inflammatory bowel disease.
LHC Group offers care to patients at home, as well as facility-based help for patients needing long-term specialized treatment, and home hospice care.
Geneos Therapeutics, a clinical stage biotherapeutics company spun out of Inovio Pharmaceuticals, raised $17 million in a private stock sale. The 6-year-old Plymouth Meeting company's Series A2 financing was led by Flerie Invest, a European venture capital firm based in Stockholm and London that specializes in backing life sciences companies tackling major medical challenges. Existing Series A investors Santé Ventures, Korea Investment Partners Global Bio Fund, and Inovio (NASDAQ: INO) also participated.
The BA.2 variant isn't yet dominant in the U.S., but theFDA has limited the use of a Covid-19 monoclonal antibody therapy thought to be ineffective against it.
Lila Ammouri, 54, and Susan Frazier, 49, were suffering from medical ‘frustrations’ and decided it was ‘time to go’
Provention Bio Inc (NASDAQ: PRVB) announced results from the final analysis of its first-in-human PROVENT study of PRV-101, a polyvalent inactivated coxsackievirus B (CVB) vaccine candidate. Provention is developing PRV-101 for the prevention of acute CVB infection and its complications and the potential delay or prevention of associated autoimmune disorders T1D and celiac disease. In this final analysis, six months following the last dose of the vaccine, PRV-101 met the primary endpoint confirm
It seems the FDA isn't going to approve the company's ALS drug before an ongoing phase 3 trial produces evidence of efficacy.
With the Omicron subvariant BA.2 spreading across Europe and Asia, experts warn a surge is expected in the U.S. "Even though I know the likelihood is all of us are going to be exposed to some extent, all of our actions play a role in making sure that wave is not quite as high as it might be if we were throwing total caution to the wind," says Kirsten Bibbins-Domingo, Ph.D, UC San Francisco COVID-19 Community Public Health Initiative head and chair of the department of epidemiology and biostatist
Kate Beckinsale, 48, went pantsless in a sheer gown at the Vanity Fair Oscars after party, and her Legs are so toned. The actress works out six days a week.
Tesla CEO Elon Musk says his coronavirus symptoms are mild, while he conjures up Greek mythological imagery to describe the disease.
Shanghai is herding Covid patients into vast quarantine centres as rare images emerged of hospital wards filling with patients in the locked down city of 26 million people.
Epidemiologists examining the biggest Chinese outbreak of COVID-19 in two years are trying to ascertain why the proportion of asymptomatic cases is so high, and what it could mean for China's future containment strategy. The number of new confirmed community transmitted cases in the major financial hub of Shanghai reached 4,477 on Tuesday, a record high, but only 2.1% showed symptoms. The share of symptomatic cases over the previous seven days was around 1.6%.
Data: Axios analysis of CDC data; Chart: Will Chase/AxiosCOVID is killing more people per 100,000 in red states than in blue states.Why it matters: "The COVID-19 pandemic removed any doubt that state policies can affect health outcomes," Virginia Commonwealth University professor Steven Woolf recently argued in JAMA.Get market news worthy of your time with Axios Markets. Subscribe for free.Yes, but: Texas, among the reddest states of all, ranks just outside the top 25 in deaths per 100,000 resid
The panel talks about the upcoming vote to legalize marijuana use on a federal level.
Oregon will no longer require people to be residents of the state to use its law allowing terminally ill people to receive lethal medication, after a lawsuit challenged the requirement as unconstitutional. In a settlement filed in U.S. District Court in Portland on Monday, the Oregon Health Authority and the Oregon Medical Board agreed to stop enforcing the residency requirement and to ask the Legislature to remove it from the law. Advocates said they would use the settlement to press the eight other states and Washington, D.C., with medically assisted suicide laws to drop their residency requirements as well.
At CarolinaEast Medical Center, the heart center hit another milestone in the battle to lower patients' risks of heart disease.
Before the pandemic, Vaishakhi Rustagi, a Delhi-based pediatric endocrinologist, found that cases of early puberty were pretty uncommon, but not unheard of: In a typical year, she would see about 20 such patients. Then the pandemic hit, and the cases started to pile up. Since June 2020, Rustagi has seen more than 300 girls experiencing early puberty, she said.Subscribe to The Post Most newsletter for the most important and interesting stories from The Washington Post. Precocious or early puberty

source

Leave a Comment

Your email address will not be published.

Shopping Cart