Dr. Jeffrey N. Weiss, a Physician, Retinal Specialist and Electrical Engineer talks about using stem cells to treat vision problems and the remarkable outcomes some patients have.
Interview conducted by Ivanhoe Broadcast News in December 2017.
You’ve been doing this a long time?
Dr. Weiss: I started this work in 2009; in 2010 I did the first ocular retinal stem cells surgery in Dusseldorf, Germany on two American patients because the FDA did not allow that here. In 2011 I did seven American patients in Vienna, Austria. And then finally in November 2012 my procedure was FDA compliant, it was consistent with FDA regulations and we were allowed to start operating here. I did my very first patient then. And since that time I’ve done more than five hundred patients. The study is called SCOTS II. We have two additional protocols now. One is called NEST which is for neurology, specifically traumatic brain injury, stroke, diabetic neuropathy, Parkinson’s disease, Chronic Multiple Sclerosis. And our third protocol is SciExVR which is for paraplegia. And we did our first patient in conjunction with a spine surgeon about three months ago and I’ve just been informed that the twenty three year old boy now has bladder sensation and is getting sensation in his legs once again. So that’s a miracle.
It is a miracle and when we’re talking miracles and I want to talk about the stem cell eye procedures for vision loss, really for blindness.
Dr. Weiss: Right.
You’ve done over five hundred, tell us what are some of the conditions these people come to you with and you’re getting patients calling you from all over the world.
Dr. Weiss: We have patients coming here from all over the world. We are the largest Institutional Review Board approved study. As you know the Institutional Review Board is monitored by the FDA. We are FDA compliant. We are then registered with the National Institutes of Health (NIH) on their website clinicaltrials.gov. We do no marketing; patients find us on the NIH website and they come to us from all over the world. We as I say only treat the untreatable. We only treat conditions that are chronic, blinding, for which there has never been and there is no other treatment. The patients really have not much to lose and they’re blind, whether legally or almost completely blind. And approximately sixty percent of all the patients we do gain some vision. Now we’ve done about forty seven different conditions and many of the conditions are mixed. So then what we do is we tease out the pure conditions because that’s necessary to publish. Now we have published five articles which is more than anybody else in this field. We have a recently published paper for Non Arteritic Ischemic Optic Neuropathy, where approximately eighty percent of people gained vision. We have a paper recently accepted for publication on Retinitis Pigmentosa where approximately forty five percent of the patients gained seven or more lines of vision. This is unheard of in the history of earth for these chronic conditions which are like in the case of retinitis pigmentosa progressive, zero people have improved. So it’s analogous to treating somebody who is dead and they come back to life.
And that condition it can come on suddenly and it can affect somebody of any age?
Dr. Weiss: Non Arteritic Ischemic Optic neuropathy comes on suddenly. It tends to occur in older people. I would say about fifty to sixty percent of the people we do have optic nerve problems, optic atrophy from many different causes. Motor vehicle accidents, traumatic brain injuries, after tumor removal, stroke in the nerve. And the remaining conditions are retinal conditions. Age related macular degeneration, Stargardts disease, Retinitis Pigmentosa, Cone-rod dystrophy, and other conditions.
Talk about the stem cell procedure itself, what is it that you’re doing? Because a lot of people hear stem cell and freak out.
Dr. Weiss: The procedure is very straight forward. We have four teams, the first team is anesthesia, the patient is asleep for the surgery and doesn’t feel anything. A board certified orthopedic surgeon takes the patient’s own bone marrow. It’s a bone marrow aspiration from the patient’s bone, the iliac crest. People have been doing this for leukemia treatment as a bone marrow transplant since the nineteen sixties. So there’s nothing strange about this.
It’s from the patient.
Dr. Weiss: It’s from the patient. And the beauty of that is unlike these manufactured stem cells that companies are coming up with- those are not your stem cells. You need to be immunosuppressed and there’s a risk of tumor formation, but because I am using your stem cells you do not need to be immune suppressed. There’s no risk of tumor formation, there’s no risk of rejection. These are yours. The third team is the company that brings in the FDA approved equipment. We even improved the separation protocol seven, eight times already to make a purer yield. We separate out the stem cells from your bone marrow aspirate using FDA approved equipment. And then the fourth team is me and my people. And I inject the stem cells around each eye. So it’s a very, very safe procedure. At this point I’m not going into your eye I’m going around your eye. And the remainders of the stem cells that are left over we give you back intravenously. And that led to the development of the neurology protocol because we saw patients who had eye problems and with neurologic problems and both conditions improved after treatment.
Why did the stem cells work, what it is doing?
Dr. Weiss: I had about fifteen to twenty percent of patients improve on the first day. And that’s probably the release of all the growth factors with the stem cells because it’s too soon for the cells themselves to be incorporated. Once the cells are there though they may stimulate the remaining cells that are already present to start functioning again. And of course later on those cells themselves can be incorporated.
Most of your patients would have this done in both eyes correct?
Dr. Weiss: Correct. If they have a condition in both eyes. But most people coming here do so because if they have one good eye then they don’t feel the necessity to have surgery on the other one. And we generally do not take people who have good vision in one eye.
Do you ever turn anyone away?
Dr. Weiss: We turn down most patients. We review people’s records for free. My Study Director Dr. Levy in Connecticut turns down a lot of patients. Ones he likes he sends to me and I turn down more. I would say approximately only five percent of the patients who apply to us ever have surgery.
And those that do they come here, they have the surgery, what’s the protocol after? Do they go home, do they stay, do they come back; how does that work?
Dr. Weiss: Normally what happens is they come here Monday, I examine them, I operate on them Tuesday and I see them postoperatively Wednesday and Friday. Certainly if they’d like to come back I’m happy to see them. I provide free exams for 6 months afterwards but if they’re coming from great distance they return to their local doctor for follow up. And we communicate with that doctor, follow up is very important. We provide a chart, we provide records, we spell out exactly what testing needs to be done. We even pay the patient for the physician who provides the testing.
For most patients, how does the vision come back? According to their experience is it gradual or does it happen right away?
Dr. Weiss: Fifteen to twenty percent see some improvement on the first day. But typically it’s four to six months for them to see improvement. Though I have one patient from the Middle East that supposedly started seeing at eight months. I have patients now wanting to have it a second time and I tell them to wait one year because I don’t want to intervene too soon. In fact, my very first patient who was a blind attorney, a young blind attorney has had it four times. He comes back every year on his anniversary and has had it. And more and more people now want it a second time to see if they can gain more vision.
What was the percentage of people who regain some vision?
Dr. Weiss: Overall with all the conditions approximately sixty percent of the people we operate on gain some vision. We’ve had now eight people go from legally blind to getting drivers licenses.
Any risk at all?
Dr. Weiss: Well in the beginning we had three Arms to the study and the Arm three had some risks, the Arm two had slight risk and the Arm one had almost no risk, but all surgery has risk. At the present time with the analysis I find that the Arm three may not be necessary so I’m not really doing many of those anymore. And the Arm two may not be necessary because in comparing the follow up data to the Arm one the results seemed to be about the same. We have never had a complication with an Arm one. But of course it’s possible because it is surgery.
Right, there’s always a risk with surgery.
Dr. Weiss: Yes, but it’s very small.
Do most patients come back to see you? In other words so they do go for a second procedure?
Dr. Weiss: Well that’s starting now because I told people to wait a year, and it’s starting with more and more. We had somebody here today to have it a second time. And again I leave it up to the patient. Frequently people from far away and may happen to be returning to Florida because they’re going to Disney or they’re going to take a cruise out of Miami and they call me up and they stop in for an exam. I like that.
That would make sense. The patient we’re going to see today, Allison do you remember?
Dr. Weiss: Well I’m not allowed to speak about patients without a release. If she gives a release I can speak about her.
In general what are the responses you’re getting from the patients?
Dr. Weiss: Almost uniformly everybody is so grateful that somebody tried and they tell me whether it works or not, I mean God bless you for trying. One of my very grateful patients was in her nineties, was blind for fifty years. And she said, for fifty years I’ve been lied to saying they’re working on it and I found out that nobody was working on it except you. So whether this works or not at least before I pass I know I tried. Hope is powerful. I had a doctor tell a patient save your money for a guide dog or accept that you’re blind and get over it. I mean really very, very cruel things where they make the patient cry. Certainly the people who have gained vision write me the most beautiful letters. I had a woman who during birth had so much blood loss she woke up blind. She never saw her baby. Now she did after this. The most common statement I hear is you gave me my life back. And that’s why I keep going. Because this is incredible. I’ve been a retinal specialist for more than thirty years. But other people can fix retinal detachments and treat with different medications. This is unique, I am advancing the field. I will not accept that somebody is blind and that’s it. I became a physician to push back the envelope of ignorance and to come up with new treatments and new methods and new inventions and new techniques to help people. It’s my privilege that they trust me to allow me to do that for them.
It’s a very unique thing to do. It is not covered by insurance?
Dr. Weiss: No. Many things that should be are not because insurance companies are profit making businesses. And if they don’t pay something out they keep the money. So they rely on things that they deem experimental. They don’t spend the money to do the experiments to prove something but anything that they can consider experimental or not standard of care, they don’t pay for. Of course they never care in these circumstances. The standard is we’re not going to help you and good-bye. And many of these people until they come to us because we insist upon a recent eye exam haven’t seen an eye doctor in years because every year they go back and the man says, I can’t help you and good-bye and here’s the bill, so they don’t go back.
How much does this cost?
Dr. Weiss: Nineteen thousand six hundred dollars. And that money is distributed to many physicians and staff and the surgery center, and the company that brings all the equipment and the disposable packs, and my pre and post op examinations and surgery and research. This piece of equipment over here was a hundred forty thousand dollars. That I developed. I invented it to make noninvasive measurements before and after surgery for people undergoing the stem cells. To quantitatively objectively confirm that the stem cells are there and having an effect.
Where can people learn more, where can they contact you?
Dr. Weiss: ClinicalTrials.gov Identifier: NCT03011541 (Scots II). The study director is Dr. Steven Levy who is in Connecticut and his contact information is on the web page.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Steven Levy, MD
stevenlevy@mdstemcells.com
203-423-9494
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