Therapeutic Solutions International Inc (TSOI)

[centsability4me]

by noslippas808 » Thu Sep 22, 2022 8:49 am

https://forum.therapeuticsolutionsint.com/viewtopic.php?t=384&start=45

CTE is an interesting topic. We have reported that as of current we, our group that is, consisting of Dr. Veltmeyer as clinician, have successfully diagnosed and treated five retired US Navy SEALS. This was all done under Right To Try and yet we are satill working through animal models with FDA to clear IND for phase 1/2. Dr. James Veltmeyer is the only physician in the USA that can diagnose CTE in a living human being. Just think about that for a moment. FDA has given us green light to diagnose and treat ahead of our IND and phased trial. You would think the NFL (we tag them on twitter on every CTE release) would be curious but I can tell you we have never had any contact. I know a bunch of ex-chargers because I live in San Diego and they know but the problem is they are all in litigation with the NFL. Not one of the players in that case have an actual diagnosis of CTE. Imagine what would happen to that case if we were to diagnose a large % with an incurable and terminal disease? Might change the payout... So because we live near Coronado and Camp Pendleton we hve decided to instead see what we can do with out local military. We would love to help the NFL, or anyone else in high risk occupation but so far the only people we have been able to help are those 5 hero's.

“The fact that the FDA accepted our definition of CTE as diagnosed in living patients is in our opinion, a major breakthrough” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “The experiments conducted demonstrate safety of the JadiCells™ in several different systems. We applaud the diligence and high level of scrutiny that the FDA has applied to our clinical trial and look forward to utilizing this novel approach to addressing this serious unmet medical need.”

“We are pleased that the FDA has thoroughly reviewed our proposed clinical trial and agrees with us that chronic traumatic encephalopathy (CTE) is a valid disease indication for potential therapeutic intervention,” stated Dr. James Veltmeyer, Chief Medical Officer of the Company and Top Doctor of San Diego. “Classically, the perception is that CTE can only be diagnosed post-mortem. The fact that the FDA is open to allowing our protocol, with minor changes, strongly supports development of regenerative-based approaches for this terrible condition.”

The FDA requested several changes to the IND and clarifications centered around manufacturing, delivery, and monitoring of the cellular product before patient treatment can be initiated.

In regard to recognition of CTE as a valid clinical indication, the FDA stated, “To limit the number of subjects being exposed to unknown but potentially significant risk(s), please modify your protocol to include an appropriate staggering period between consecutive subjects for the first several subjects.” Additionally, the FDA requested that the Company potentially exclude pediatric patients and patients unable to provide proper informed consent.



by TimGDixon » Thu Sep 22, 2022 9:03 am
Not exactly sure what you mean. The IND # 27377 has already been filed and issued serial number. FDA asked for additional animal studies (as they always do) and I think we will soon have the data to supplement with. Outside the IND the FDA had asked us to limit (under RTT) the first few patients with ample time between each which we did and then diagnosed and treated 3 more. Once we submit this data then the drug master file kicks in and there won't be any more delays to study mice and we should get green light to proceed. But, with FDA anything can change any time.

“To limit the number of subjects being exposed to unknown but potentially significant risk(s), please modify your protocol to include an appropriate staggering period between consecutive subjects for the first several subjects.”