Therapeutic Solutions International Inc (TSOI)

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Therapeutic Solutions International (TSOI)

is focused on immune modulation
for the treatment of several specific diseases

On the Right To Try Pathway for Treatment, Prevention, or Treatment and Prevention of :

Stage 1 - 4 Cancers (Tumor types), w/ StemVacs Dendritic Cell Vaccine / Immunotherapy Platform
CTE - Chronic Traumatic Encephalopathy w/ Mesenchymal Stem Cells, Autologous Stem Cell Banking, and NeuroStilbene
TBI - Traumatic Brain Injury w/ Mesenchymal Stem Cells, and NeuroStilbene
CRS - Cytokine Release Syndrome / Inflammation w/ NanoStilbene

The Right to Try Pathway :

FDA Right to Try info for patients:

https://www.fda.gov/ForPatients/Other/ucm625115.htm

The Right to Try Act, or the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, was signed into law May 30, 2018. This law is another way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain unapproved treatments.
right to try

Clinical trials provide information about whether a product is safe to use and can effectively treat or prevent a disease. People may have many reasons for participating in clinical trials. In addition to contributing to medical knowledge, some people participate in clinical trials because there is no treatment for their disease, treatments they tried have not worked, or they are not able to tolerate the current treatments.
For patients with serious or immediately life-threatening diseases, the FDA is committed to facilitating access to investigational medicines while protecting patients and making sure that they are able to make informed decisions. Therefore, for more than three decades, FDA has facilitated such access as a part of FDA’s Expanded Access program.

Building on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, the FDA is providing information for patients on the Right to Try Act.

The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs.

An eligible patient is a patient who has:

Been diagnosed with a life-threatening disease or condition
Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)
And has provided, or their legally authorized representative has provided written informed consent regarding the eligible investigational drug to the treating physician

An eligible investigational drug is an investigational drug:

For which a Phase 1 clinical trial has been completed
That has not been approved or licensed by the FDA for any use
For which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA
Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDA

If you are interested in Right to Try, you should discuss this pathway with your licensed physician. Companies who develop and make drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under Right to Try and if they are able to provide the drug/biologic under the Right to Try Act.

The full text of the Right to Try Act, Public Law 115-176, can be found on US Congress’s website: Public Law 115-176.

Who is in charge of pre-approval access decisions ?
https://med.nyu.edu/pophealth/divisions/medical-ethics/compassionate-use

The companies developing new medical products are the key decision-makers in determining whether to provide access to their investigational medical products. This is the case for both expanded access and right to try. Furthermore, companies that are willing to provide investigational products get to decide which pathway they’ll use. For example, a physician may seek access to a drug via right to try, but the company may inform the physician that it will provide it only via expanded access pathway, or vice versa.

In expanded access, a physician requests an investigational product from a company, providing information about the patient(s) who would receive the product. If a company agrees to provide it, two more entities must review the proposed treatment plan: the FDA and, unless use of the product is deemed an emergency, an institutional review board (IRB).

In right to try, a physician requests an investigational drug from a company, providing information about the patient who would receive it. If a company agrees to provide it, no FDA or IRB approval is required (unless the facility where the product will be administered requires IRB review). Currently, we are aware of one company, Therapeutic Solutions International Inc., that is purportedly making its stem cell prod available through the right to try pathway. However, we are unclear if any physicians have requested this product for their patients.