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Thread: stemcells inc clinical trials for AMD

  1. #1

    stemcells inc clinical trials for AMD

    Hi, (this is not for sci but does have to do with stemcells so should be an interest)

    Anthony's (lunasicc42) grandmother (over 80) is eligible to be a participant in Stemcells, Inc. clinical trials for dry form of age-related macular degeneration (AMD) in Palo Alto, CA. They will be using Human Central Nervous System Stem Cells (HuCNS-SC) into one eye for safety and efficacy.

    She is losing her eyesight and she lives nearby. The family was thinking about it but when a screening nurse said she would have to give her something that would compromise her immune system for 3 to 4 months prior to the treatment so the stem cells have a better chance of surviving this concerned us. Will someone on here please explain what that is and do you think it is wise for a person that age to compromise their immune system for this treatment, or is it insignificant.

    http://www.stemcellsinc.com/Therapeu...rial-Sites.htm

    http://clinicaltrials.gov/ct2/show/N...uCNS-SC&rank=1

    Thank you.
    Cindy Waters
    mom to Anthony, right c5, left c4 (24yo)
    injury march 2003

  2. #2
    Super Moderator Sue Pendleton's Avatar
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    Cindy, the trial nurse, probably the one who did the screening, should be able to answer all your questions. The idea of lowering a person's immune response is so their body will not reject the foreign stem cells. From what little reading I have done on the theory of curing different types of blindness using stem cells the eyes have a barrier much like the blood/brain barrier. That should mean that cells injected into the eye area will stay there and not move further into the body. If that is true then I would guess that they would not severely compromise the trial participants' immune systems as they would for, say, a kidney transplant. If your Mom is in otherwise good health and has had all vaccines someone her age should such as pnuemonia, flu, shingles, etc. and does not live in a nursing home or is otherwise exposed to a lot of possible germs like, oh, if you ran a daycare in the place she lives I would think the risk would be worth the possible benefits.

    If this was me and my Dad was losing his sight we'd get all the information possible and talk to his other doctors about his overall immune system currently. Then it's a call between if your Mom (I'm assuming since she is Anthony's grandmother) is rather healthy and lively still and has many good years ahead of her so her sight would be important versus is she beginning to show other signs of aging where she might not out live the entire process and follow up. Most people her age seem to have a rather good idea where they are healthwise and what they consider a good quality of life. Listen to your Mom once you have a better idea of the degree of immune suppression they will use but also remember it is a temporary suppression.

    I'm sure Wise will chime in with a better idea of what drugs are used and how they effects seniors.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  3. #3

    amd

    thank you. We are in FLA and most family is out in CA and more access to talking to Drs. and the ppl doing this trial. We had this forum as a resource that is great. I do hope to hear from others and wise too so I can pass this along. I need to get more information on why they are saying surgery. I thought it was an injection, but maybe they consider that surgery.
    Cindy Waters
    mom to Anthony, right c5, left c4 (24yo)
    injury march 2003

  4. #4
    Super Moderator Sue Pendleton's Avatar
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    My Dad had cataract surgery last year on one eye. How they call a 15 minute procedure that includes twilight sedation surgery confuses me too. Maybe because it is done in a hospital surgical suite and is invasive if only with needles and will most likely also include sometime of sedation. Dad was so happy with his first "surgery" that he's having the second, much smaller cataract removed later this summer because it bothers his night driving a little.

    From what I read on their web site it is an injection. Due to where they want to inject the cells my guess is their injection will take longer than using a scapel to remove a cataract. They'll most likely use something to hold the patients' heads steady and then some sort of imaging to guide the injections.

    Can the family out there get you a copy of the information they give your Mom about the procedure too?
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  5. #5
    Quote Originally Posted by waters3 View Post
    Hi, (this is not for sci but does have to do with stemcells so should be an interest)

    Anthony's (lunasicc42) grandmother (over 80) is eligible to be a participant in Stemcells, Inc. clinical trials for dry form of age-related macular degeneration (AMD) in Palo Alto, CA. They will be using Human Central Nervous System Stem Cells (HuCNS-SC) into one eye for safety and efficacy.

    She is losing her eyesight and she lives nearby. The family was thinking about it but when a screening nurse said she would have to give her something that would compromise her immune system for 3 to 4 months prior to the treatment so the stem cells have a better chance of surviving this concerned us. Will someone on here please explain what that is and do you think it is wise for a person that age to compromise their immune system for this treatment, or is it insignificant.

    http://www.stemcellsinc.com/Therapeu...rial-Sites.htm

    http://clinicaltrials.gov/ct2/show/N...uCNS-SC&rank=1

    Thank you.
    Cindy,

    The clinical trials dot gov site said "Immunosuppressive agents will be administered orally to all subjects for a period of three months after surgery." It is not clear what this is. If they are going to use oral methylprednisolone, I think that it would be fine. Methylprednisolone is a corticosteroid and can be taken orally but will need to be tapered at the end of 3 months.

    I know that Stem Cells Inc. used cyclosporin in an earlier trial in Balgrist (Switzerland) but it probably would be a good idea to find out what drug they are proposing to use this time. The immunosuppressive drugs should be be specified, as well as the dose, on the http://clinicaltrials.gov site. It is not sufficient to say an 3-month course of immunosuppressive drug.

    If Anthony's grandmother is healthy and does have any condition which would put her at risk for infectious diseases, a 3-month course of oral cyclosporin at a reasonable dose should not pose a significant risk. I think that tacrolimus has similar safety paramaters.

    It would be useful to find out whether they have unpublished animal data that suggest more benefit of this therapy that what the literature shows.

    Here is something else that might be of interest. I recently met the top Chinese opthalmologist in China and she showed me data that suggests that fetal retinal stem cells transplanted into the subretinal space of people with age-related macular degeneration were not rejected over a period of more than a year, even though the patients did not receive any immunosuppressive drugs. It is possible that the company does not know this, since this is unpublished data.

    Wise.
    Last edited by Wise Young; 05-19-2013 at 04:59 AM.

  6. #6
    thank you Dr. Wise. I have not read this clinical trial's verbage yet just browsed through and mainly realized they are talking all gobeldy gook to me, it is hard for the layman to understand what they write regarding trials. I will pass this comment to the family out there and hopefully they will pass to the screening nurse and see if that helps them with their decision.
    Cindy Waters
    mom to Anthony, right c5, left c4 (24yo)
    injury march 2003

  7. #7

    More proof that stem cells will work!

    Patient in ACTC Stem Cell Clinical Trial With Dry AMD Goes from Legally Blind (20/400) to Near Normal Vision (20/40)

    Irv Arons

    As you may know, Advanced Cell Technology is currently running three stem cell clinical trials; two for treating Stargardt’s Disease, one in the U.S. and one in the UK; and one clinical trial in the U.S. for treating the dry form of AMD.
    Due to a unique set of circumstances, it was disclosed that one of the dry AMD patients has gone from 20/400 (legally blind) to 20/40 (near normal vision). This is an amazing development.
    Here is the story behind the story of how this disclosure occurred.
    To read the story, please follow this link.
    Here is a link to the company’s press release concerning the development.

    http://eyedocnews.com/007096-patient...l-vision-2040/

    http://www.bio-wire.com/?p=1418
    Last edited by ineedmyelin; 05-20-2013 at 12:29 PM.
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