Creative Medical Technology Holdings Inc (CELZ)

[StemCelzRock]

This is HUGE!!!

https://www.politico.com/newsletters/prescription-pulse/2018/12/17/shutdown-watch-457438

STEM CELL COMPANY PLANS TO USE RIGHT-TO-TRY — Therapeutic Solutions International said last week it plans to make its adult stem cell treatment available to patients with chronic traumatic encephalopathy and traumatic brain injury through the new right-to-try process, which lets patients request access to experimental drugs without FDA oversight.

The product, known as the Jadi Cell, is generated from umbilical cords, which are available in large quantities at inexpensive prices, the company said in a statement. The cells have demonstrated safety in animal models with brain injury and pilot human trials for chronic obstructive pulmonary disease. There are no human data for treatment of CTE or TBI, Thomas Ichim, who sits on the company’s board of directors told Prescription PULSE.

Ichim said the company has established an independent Institutional Review Board to evaluate whether patients should be given the product under right-to-try. The IRB will “make sure that it is a situation where we are not taking advantage of the patient,” that there is some rationale the treatment will help the patient and ensure there are no other options, he explained. Depending on the amount needed, the company will give some right-to-try patients the product for free, while others may be charged so the company can recover costs.

One of the primary reasons the company is going with right-to-try over FDA’s compassionate use process, Ichim said, is he prefers the liability protection offered to companies under right-to-try versus FDA’s pathway.

Regenerative medicine companies seem to be the main players gravitating toward right-to-try (at least those discussing it publicly). Among those planning to offer products under the six-month-old law, S. 204 (115), are Pluristem Therapeutics through WideTrial Inc. and Creative Medical Technologies. Meanwhile, Batu Biologics is working on technology that would help it match cancer patients with treatments under right-to-try. BrainStorm Cell Therapeutics had planned to provide its ALS treatment through the law but backtracked due to funding concerns.