Monday, July 8, 2013

FACE + HAND TRANSPLANTS : NEW NAME, NEW REGULATORY NICHE

Clinical transplantation has moved forward in leaps and bounds, surpassing the speed of the U.S.  government in addressing regulatory standards for new transplant types. This is neither an irrelevant nor a minor issue and has just been definitively addressed by the Final Rule published in the July 3, 2013 Federal Register. The National Organ Transplant Act (NOTA) originally enacted in 1984 had defined a specific list of transplant organs based on all of the transplant types that were performed in that era. The Organ Procurement and Transplantation Network (OPTN) and United Network for Organ Sharing (UNOS) oversee and regulate those types of organ transplantation with a fully developed set of bylaws for member institutions and policies that determine how transplants are undertaken. These transplants currently include:

ORGAN TRANSPLANTS
Kidney
Liver
Heart
Lung
Pancreas
Intestine (any part of the intestinal tract)

In contrast, human cells or tissue for transplantation are under the regulatory jurisdiction of the Food and Drug Administration (FDA) under Section 361 of the Public Health Service Act and 21 CFR parts 1270 and 1271.  Examples (not inclusive) of Cell and Tissue "Implants/Transplants" include:

CELL + TISSUE "IMPLANTS/TRANSPLANTS" 

Bone
Skin
Cornea
Ligaments
Stem cells
Peripheral blood
Cord blood
Oocytes
Semen

Face, hand, larynx, and abdominal wall transplants are all examples of transplants that did not clearly fit into either of the two pre-existing categories. Agreeing with advocates within the transplant community, the Secretary of Health and Human Services issued this Final Rule that has formally created a new category of Vascularized Composite Allografts (VCA), (allograft = transplant between non-identical members of the same species) that is defined based on functions below (ischemia is a period of interrupted blood, see below):

VASCULARIZED COMPOSITE ALLOGRAFTS 
  1. Vascularized - requires blood flow by surgical connection
  2. Contains multiple tissue types
  3. Recovered from a human donor as an anatomical/structural unit
  4. Transplanted into a human recipient as an anatomical/structural unit
  5. Minimally manipulated or processed (but may be cut or shaped)
  6. For homologous use (i.e., to be used for the same purpose in the recipient as it was in the donor)
  7. Subject to ischemia and therefore stored only temporarily
  8. Subject to allograft rejection and generally requiring immunosuppression
The Final Rule also clearly stipulates that VCA transplants fall under the jurisdiction of the OPTN/UNOS, not the FDA. Major implications of this definition are that VCA transplants may only be performed at OPTN member institutions in good standing. New policies specifically applicable to VCA transplants clearly need to be developed by the OPTN/UNOS.

Because of the unique issues pertaining to donor consent for these specific transplant types, wherein donor identification may be retained (e.g., fingerprints and facial identifiers), the Final Rule implies that donor specific consent should be undertaken on a case-by-case basis. This is the current ad hoc practice. But new issues of allocation will arise if the number of transplants begins to grow substantially. For example, there is no other transplant type in which skin color may be relevant!

Overall, a new field of medicine is currently developing at a very rapid pace. This one step is an important one. It will be challenging and exciting as others are made. Stay tuned.

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  4. My Name is AZIBA OLUBOISE. I never believed in Love Spells or Magics until I met this special spell caster when i contact this man called johnyiyi@rocketmail.com Execute some business..He is really powerful..My wife divorce me with no reason for almost 4 years and i tried all i could to have her back cos i really love her so much but all my effort did not work out.. we met at our early age at the college and we both have feelings for each other and we got married happily for 5 years with no kid and she woke up one morning and she told me she’s going on a divorce..i thought it was a joke and when she came back from work she tender to me a divorce letter and she packed all her loads from my house..i ran mad and i tried all i could to have her back but all did not work out..i was lonely for almost 4 years…So when i told the spell caster what happened he said he will help me and he asked for her full name and her picture..i gave him that..At first i was skeptical but i gave it a try cos have tried so many spell casters and there is no solution…so when he finished with the readings,he got back to me that she’s with a man and that man is the reason why she left me…The spell caster said he will help me with a spell that will surely bring her back.but i never believe all this…he told me i will see a positive result within 3 days..3 days later,she called me herself and came to me apologizingI NEVER BELIEVED IN LOVE SPELLS UNTIL I MET THIS WORLD'S TOP SPELL CASTER. HE IS REALLY POWERFUL AND COULD HELP CAST SPELLS TO BRING BACK ONE'S GONE,LOST,MISBEHAVING LOVER AND MAGIC MONEY SPELL OR SPELL FOR A GOOD JOB.I'M NOW HAPPY & A LIVING TESTIMONY COS THE WOMAN I HAD WANTED TO MARRY LEFT ME 2 WEEKS BEFORE OUR WEDDING AND MY LIFE WAS UPSIDE DOWN COS OUR RELATIONSHIP HAS BEEN ON FOR 2YEARS... I REALLY LOVED HIM, BUT HIS MOTHER WAS AGAINST US AND HE HAD NO GOOD PAYING JOB. SO WHEN I MET THIS SPELL CASTER, I TOLD HIM WHAT HAPPENED AND EXPLAINED THE SITUATION OF THINGS TO HIM..AT FIRST I WAS UNDECIDED,SKEPTICAL AND DOUBTFUL, BUT I JUST GAVE IT A TRY. AND IN 7 DAYS WHEN I RETURNED TO USA, MY GIRLFRIEND(NOW WIFE) CALLED ME BY HERSELF AND CAME TO ME APOLOGIZING THAT EVERYTHING HAD BEEN SETTLED WITH HIS MOM AND FAMILY AND SHE GOT A NEW JOB INTERVIEW SO WE SHOULD GET MARRIED..I DIDN'T BELIEVE IT COS THE SPELL CASTER ONLY ASKED FOR MY NAME AND MY GIRLFRIENDS NAME AND ALL I WANTED HIM TO DO... WELL WE ARE HAPPILY MARRIED NOW AND WE ARE EXPECTING OUR LITTLE KID,AND MY WIFE ALSO GOT THE NEW JOB AND OUR LIVES BECAME MUCH BETTER. IN CASE ANYONE NEEDS THE SPELL CASTER FOR SOME HELP, HIS EMAIL ADDRESS IS;shakesspear23@yahoo.com OR shakesspear23@gmail.com ......HOPE HE HELPS YOU OUT OUR OPPORTUNITY ... CONTACT THIS GREAT SPELL CASTER VIA EMAIL:shakesspear23@yahoo.com OR shakesspear23@gmail.com...

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  5. Been a HIV positive is just like been through hell but EVERYTHING IS POSSIBLE. So amazing and i want to testify of the good work done by GREAT BABA a very strong and powerful spell caster. GREAT BABA has proved science and scientists wrong for believing and thinking that there is no cure for HIV AIDS but to be sincere this GREAT MAN is so real and powerful. I never thought that this spell will work but this GREAT MAN has proved it to me and it has worked and still working perfectly. My Name is Randy Scott and i was diagnosed of the deadly disease called HIV AIDS in 2011 and i thought that is the end and there will be no hope. Speaking to anyone was always a problem because i was so worried and always in the state of unrest in fact i thought it was over until one blessed day when i was searching for help here on the internet, i came across a testimony about GREAT BABA on how he helped a lady who was HIV positive. At first i thought it was all a lie but i decided to give it a try since there was no option and, when i contacted this MAN he laughed and told me that, that is too small for him to handle but i was still in doubt, and he gave me a form to fill which I did, then he called me and told me that his gods required some items in which he will use in casting a curing spell on me and he told me that it will cost only $500, I sent him the money because I could not find the items. He bought the items and prepared a cure for me, and instructed me on what to do and i OBEYED him completely as he told me. Then he sent a parcel to me through the courier delivery service. I paid for the courier service, I got my parcel, it was a holy water and a pure holy oil as described by GREAT BABA. I took the holy water and the holy oil and after taking it, he told me to go for check up but I was still in doubt and was so afraid to go for the test but i took a bold step and believed that it is well, and i believed all what he has done and all that he has told me. So i went to the hospital for the test it was so amazing, awesome and exciting what seems to be impossible became possible, the VIRUS disappeared completely from my system and I was tested HIV negative. Quickly I called him and told him what happened he congratulated me and today i am a happy man again the way things use to be. Don't you think that this testimony is worth sharing? I promise to tell the world about him and i will keep sharing this testimony till the end because many people has died of AIDS and i want many people who believed that it is over to know that EVERYTHING IS POSSIBLE AND I WANT THEM TO GET HELP FROM THIS SPELL CASTER by contacting him on his email at shakesspear23@yahoo.com OR shakesspear23@gmail.com for your solution now. If you are hiv positive and you think that it is over i want to tell you that there is hope for you and if you truly and dearly value your life please contact him now. THIS IS REAL HE IS NOT A SCAM, BELIEVE HIM AND DON'T ASK TOO MUCH QUESTIONS. Thank you GREAT BABA and May your good gods keep rewarding you for your good deeds. HIS EMAIL AGAIN IS: shakesspear23@yahoo.com OR shakesspear23@gmail.com

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  6. Need a spell caster?then think of Shakes Spear he is real reliable and he does what he promise you.I know all this because he helped with my marriage problem.For security reason i will not live my name here but i can tell you all he did to help me.Me and my family live in the US military base here in America,my wife is a solider and i love it that she is and i support.But being a solider means she is half my wife and fully the U.S army.before her three tour we were so in love and we had a kid son who we both love him.It all changed after her two tour in Iraq and Afghanistan,i noticed the distance her second tour she stopped call at first i thought maybe she was part of an accident but i found out that she was OK in Afghanistan.She explained that she always on patrol.It got ugly on the third. I guess in the last two tours she found herself a new lover and then totally forgetting me and our boy.I can not say i did not notice because she always has to be some where instead of with me,coming up with some silly excuse not to be with me that is ( have sex ) and her entire behavior told me all i needed to know. i did my research and i had a hint that it was her squad lieutenant.I had know evidence so a could not take the matter to any body.It killed me to seeing this happen i was going suicidal.What hurt me the most was she going home knowing that i suspect she infidelity,she kept lying to me over and over again.The power of positive thinking helped me a lot.I thought that maybe i can find in the help on the internet with the people who had being in the same problem with him.I found a lot of ways but nor worked except Shakes Spear spell.At that time five month ago i was so confused that i could do anything to get my wife back so i contacted Shakes Spear with his email address i saw in some comment on the internet at shakesspear23@yahoo.com.I laid down my problem to him and told him the entire story and he even confirmed my hint was right, how he did i do not know but he was right because my wife told me later after the spell was made effective. Shakes Spear cast a spell on them both do not know what he did but it seem he made them both forget they ever crossed path romantically speaking like they never know each other expect there official relationship that is squad leader and solider.I owe my life to John Yi Yi what he did saved my marriage.I can tell you this because i have tried and it worked for me.Your case also have a solution with Shakes Spear contact him with his email shakesspear23@yahoo.com OR shakesspear23@gmail.com

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  7. Reading SLY SLIMMERS article about a spell caster namely Shakes Spear was, i will say the best that ever happen to me this year based on the fact that i had a lot problem that i was trying to over come.I had problems at home which affected my work greatly. I was now always in a cross fire with my boss.I really don't want to tell story here so i guess i would just go strange to the point on what i have to say.My wife wanted out of our marriage for no just reason.We were married for four year and i think we were happy though we had no kids, it was her idea not to have any cos she wasn't ready to be a mom yet and i was okay with it i mean i didn't like the idea but i went along with it just to please her.It was always like that i mean she always get what she wants.All i wanted was to see her happy i could never do anything that will make her so unhappy.This was all i did wrong that is make her have it her way all the time. I mean that was the reason she gave during our therapy session.She wanted out of the marriage cos i was to nice. From what she said, i was the kind of man ever woman will die for but she wanted a real man to enforce his will no her meaning was i was to week a man for her.And that was the least of therapy session we had cos like she said we where wasting our life together and no amount of therapy was going to get us back together.I was a total mess thinking of how i was being dumped based on how much i loved my wife and how good i treated her,I really didn't know if she was ungrateful or just confused about what she wanted that is mid-life crisis but the bottom line is that she left me and who knows maybe for another man.I was still in love with her, she was the love of my life and i still wanted her to come back that was when i saw Eva-Yolanda article on Shakes Spear.When i contacted him he made me known that i will have to go through all the spell casting process.Like he said most people are too scared cos of trust issues.I had trust issues, but getting my wife back was my ulterior motive and from my experience with Shakes Spear i can tell you he is 100% truthful and honest with his customer.I was asked to get some material to prepare the spell and after which he sent me a package contain the spell and the rest just happen the way it was suppose to happen i got my wife back and she was my wife back again i mean she was not that woman who wanted a hard man she was woman i fell in love with who loved me cos i am me.If you want help or fell he can help contact him with his email address shakesspear23@yahoo.com OR shakesspear23@gmail.com..... ONCE AGAIN HIS EMAIL ADDRESS IS: shakesspear23@yahoo.com OR shakesspear23@gmail.com

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  8. ATTENTION TO THE WHOLE WORLD:


    Hello and blessed are you who found me. My name is DR SHAKES SPEAR, and am here to help you change and transform your life in the most positive way possible. I use the power of white, black craft and Wicca and voodoo spell casting to help people just like you they get the love they want and the money they deserve.


    My love spell offer amazing and quick results. Do you want to find your soulmate? Do you want to reunite with a past lover and make him or her love you again? Do you need to bind a troublemaker from causing problems in your relationship? With my spell casting service, I can cast a love spell on your behalf that will help all of your wishes and dreams come true. I also do other custom spells, such as money spells, job spells, friendship spells, and good luck spells.


    You may have already tried the power of spells and prayers to get what you want. Although it is true that everyone has the ability to cast spells and perform magic, spell casting is like a muscle. Everyone has this 'muscle' but the more you use it, the stronger it gets, and the more things you are able to do with it. If you are not an experienced spell caster, your spell may not be as strong, and the results not as quick as you may desire.GET YOUR PROBLEMS SOLVE HERE AND BE FREE!!

    Hello to people that want to be Great,

    Note: This Spell casting do not have any effect on any one, But just to get your problem solve ok.
    Get your problem solve in master...You can get the bellow problems solve here.

    1. Bring back lost lover, even if lost for a long
    time
    2. Remove bad spells from homes, business
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    I have over 20 years of spell casting experience, and i have successfully cast spells to help hundreds of people improve their love life, financial situation, and happiness.

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  9. Hello To The World At Large,
    I am Miss Wacks.,From united states of America.I will start by saying to all that have experience heart break and also cant do with out there lover should please stop here and read up my story, So as you will know how to go solving or getting your ex back from this spell caster..AND AGAIN I WILL WANT TO ALSO TELL ALL THAT THIS SPELL CASTER I WILL WANT TO TELL THE WHOLE WORLD ABOUT IS HARMLESS AND DO NOT HAVE ANY SIDE EFFECT, BUT TO RESTORE AND GIVE YOU BACK WHAT YOU DESERVE, COS WHEN I MEET WITH THIS SPELL CASTER THAT WAS INTRODUCED TO ME BY THE WIFE OF MY BOSS IN MY WORKING PLACE, HE MADE IT CLEAR THAT HE CAN CAST SPELL ON SO MANY OTHER PROBLEMS EXCEPT IN GETTING YOUR EX OR MAKING YOUR LOVER TO LOVE YOU MORE THAT WILL SUITE YOU. Last year December, My lover was cheating on me and was not also give me the attention that a man should give to a woman,And really that was troubling my mind and tearing my heart apart to the extent that i was not concentrating in the office the way i use to before the break up by my lover.And before that incident,I always see how my boss use to love his wife so much. I was binging to think that i was not doing the right thing to him that will make him love me forever,So i really gathered my courage and went to my boss wife office to ask her the secret that made her husband love her so dearly,In the first place she refused in telling me,She asked me why i am asking her such a question,That if is it not normal for every man to love his wife.I told her the reason that made me ask her about this question,That my lover started cheating on me lately,When i knelt down before her for her to see my seriousness in this issue that i went to ask her,She opened up to me by telling me that i should not tell anybody about what she want to tell me,The wife to my boss started to say to me that she used a very powerful spell on his husband to love her,And the spell that she used is harmless, But the spell is just to make him love her and never to look for any other woman except her. I QUICKLY ASK HER HOW DID SHE GET TO KNOW THIS GREAT,POWER,DURABLE AND PERFECT WORK SPELL CASTER,she said that a friend of hers also introduce her to him. Then i also ask her how i can meet with this spell caster.SHE SAID EVERYTHING TO ME,THAT THE NAME OF THIS SPELL CASTER IS SHAKES SPEAR ORACLE TEMPLE.My next question to her was how can i get this wonderful spell caster,She said she is going to give me the email of the spell caster for me to contact him for my problem,Really she gave to me this spell caster email and i contacted him and explained all to him,And after every thing that needed to be done by the spell caster, In the next two days, My lover that hated me so much came to house begging for forgiveness and i was so glad that i have finally gotten my heart desire..I was so grateful to this spell caster for what he has done for my life.. So i made a promise to him that i will always continue telling the world about his wonderful work towards me and also to other that came to you before and also the people that will also get to you from my story that i narrated online now..I will want to say to the entire world that you should not cry over noting again, That there is a great man that has been helping individuals to restore there Joy and smile in there faces !! The direct email to get this man is : shakesspear23@yahoo.com OR shakesspear23@gmail.com ,This is what i want to tell you all out there,That is thinking that all hope is lost ok.CONTACT SHAKES SPEAR TODAY:: shakesspear23@yahoo.com OR shakesspear23@gmail.com .Thanks

    Regards,

    Miss Wacks.

    ReplyDelete
  10. My Name is Dan Anelos ..I never believed in Love Spells or Magics until I met this special spell caster when i contact this man called shakesspear23@yahoo.com Execute some business..He is really powerful..My wife divorce me with no reason for almost 4 years and i tried all i could to have her back cos i really love her so much but all my effort did not work out.. we met at our early age at the college and we both have feelings for each other and we got married happily for 5 years with no kid and she woke up one morning and she told me she’s going on a divorce..i thought it was a joke and when she came back from work she tender to me a divorce letter and she packed all her loads from my house..i ran mad and i tried all i could to have her back but all did not work out..i was lonely for almost 4 years…So when i told the spell caster what happened he said he will help me and he asked for her full name and her picture..i gave him that..At first i was skeptical but i gave it a try cos have tried so many spell casters and there is no solution…so when he finished with the readings,he got back to me that she’s with a man and that man is the reason why she left me…The spell caster said he will help me with a spell that will surely bring her back.but i never believe all this…he told me i will see a positive result within 3 days..3 days later,she called me herself and came to me apologizing and she told me she will come back to me..I cant believe this,it was like a dream cos i never believe this will work out after trying many spell casters and there is no solution..The spell caster is so powerful and after that he helped me with a pregnancy spell and my wife got pregnant a month later..we are now happy been together again and with lovely kid..This spell caster has really changed my life and i will forever thankful to him..he has helped many friends too with similar problem too and they are happy and thankful to him..This man is indeed the most powerful spell caster have ever experienced in life..Am Posting this to the Forum in case there is anyone who has similar problem and still looking for a way out..you can reach him here:shakesspear23@yahoo.com OR shakesspear23@gmail.com... CONTACT THIS GREAT AND POWERFUL SPELL CASTER CALLED SHAKES SPEAR ... HIS EMAIL ADDRESS IS :shakesspear23@yahoo.com OR shakesspear23@gmail.com... CONTACT HIM NOW AND BE FAST ABOUT IT SO HE CAN ALSO ATTEND TO YOU BECAUSE THE EARLIER YOU CONTACT HIM NOW THE BETTER FOR YOU TO GET QUICK SOLUTION TO ALL YOUR PROBLEMS...

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