Back again the same day. The pups were in the pool and then decided to roll in the dirt…again. I showered them two nights in a row. Bathroom looked like a typhoon hit both times. Not doing that again.
That means sit with them outside until they dry, and I can brush the dirt off. And that means another page on the study.
Continued from Stem Cell Study Part 1.
They will be running nine people in the phase 1 study. You might recall numbers are very small in phase 1. There will be 141 people in the phase 2 study. Phase 2 studies have more people but they do not involve a multitude.
Because the research protocol requires the use of immunosuppressants, extensive cancer screening is required before the study. Cancer risk, and it seems skin cancer risk especially, is higher if you have a compromised immune system.
Something I don’t remember seeing before is the requirement that the subject have a negative tuberculosis test. That may have very well ruled me out at the very beginning. 40 years ago I had a positive tine test, and I have been told there is a scar on my lung.
There are all sorts of tests and screening that have to occur before the actual procedure. The researchers want to be sure there will be very few problems coming up during the actual research.
A point the materials make that cannot be stressed enough is legitimate research will only be working on ONE of your eyes. If the “research” or “treatment” you are involved with wants to do both eyes at the same time, refuse and minimally seek a second opinion. Better, run out of there and don’t go back. Remember that is what happened to the women in Florida and they are now blind.
We talked about this when I first was looking at this study. The actual surgery for this procedure is a vitrectomy. A vitrectomy requires the surgeon to make incisions in your eye and then draw out the vitreous “gel” from your eye. They replace it with air or saline or sometimes oil. The vitreous gel will refill but it takes time.
With vitrectomies there is also an excellent chance of developing cataracts. 80% chance in fact. The informed consent form talks about this and all sorts of other side effects. A legitimate study will do that.
Remember with legitimate research they pay you. You do not pay them. The rate for this study is $75 a visit. Over the five-year time period of the study, subjects are expected to earn $1800. Not a king’s ransom but better than paying thousands for a bogus treatment.
These are just some of the things I wanted to highlight from this 46-page document that I received. These are things you see in a legitimate research study being put on by an internationally known researcher at the number 2 eye institute in the country and sponsored by a huge pharmaceutical company. This is the way things should be done. Don’t settle for less.
Written July 7th, 2018