Pluristem Therapeutics Inc (PSTI)

[HappyBee]

Hi Saud,

The study appears to involve only patients with CLI Rutherford Category 5. Please see quote and relevant link below. There is also a reference to the number of injections administered to the trial participants.

"Pluristem’s Phase III CLI study will be a double blind, randomized, placebo controlled trial of about 250 patients with CLI Rutherford Category 5 who are unsuitable for revascularization. At an estimated 40 clinical sites in the U.S. and Europe, patients will be treated with 300 million PLX-PAD cells or placebo, injected twice intramuscularly (IM), with the second injection administered two months after the first."

https://www.clinicalleader.com/doc/pluristem-s-phase-iii-study-of-plx-pad-cells-critical-limb-ischemia-cleared-by-u-s-fda-0001

The quote below is from the September 2016 company presentation.

"Study design for U.S. Pivotal Phase 3 Trial

Dosing regimen: two doses of 300 million cells two months apart"

After reading about clinical trial procedures on the GovTrial website, see quote and link below, I would have thought that any participant would be adequately supported throughout the clinical trial process. Perhaps the person who claims to be a trial participant would benefit from discussing his/her current concerns with the research team.

"The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document before joining a study to show that he or she was given information on the risks, potential benefits, and alternatives and that he or she understands it."

https://clinicaltrials.gov/ct2/about-studies/learn#Questions

HappyBee