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Thread: For those who understand spanish (Dr. Vaquero)

  1. #21
    Quote Originally Posted by Isildur View Post
    This is the difference between the will to find a cure, and make money/business from SCI. Dr.Vaquero and APINME are doing this with a lot less resources than the big orgs like Miami Project or ICORD.
    Maybe a business model is needed?

  2. #22
    Quote Originally Posted by Chaz19 View Post
    Maybe a business model is needed?
    Personally, I would urge any researchers who have a promising strategy to buck the trend of the biotech/pharma model completely and align themselves with entrepeneurial SCIs/groups to find the resources to translate to the clinic reducing the risk of the strategy getting caught up in the quagmire. It seems Vaquero is trying to do this.

    The last thing we want is for more promising strategies to be hamstrung in decade-long patent wars.

  3. #23
    keep (rolling) Walking

    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  4. #24
    Senior Member KIM's Avatar
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    The latest:
    Estimados amigos/colaboradores de la ASOCIACION APINME

    Como sabéis algunos este pasado d?*a 22 de Junio de 2012, los representantes de APINME (David Aviles , Federic Crespo, Xaxi Esteva y Jose Vicente Cuines), mantuvimos una important?*sima reunión en el Hospital Puerta de Hierro con el Equipo de Investigación (Doctor Jesus Vaquero), el Director de la Fundación Biomédica para Investigación (D. Jesus Cubero), y el Gerente del Hospital (D. Jorge Gómez Zamora).

    El motivo principal de la reunión era, conocer de primera mano y de forma concreta el porque de que los ENSAYOS CLINICOS CONSISTENTES EN LA TERAPIA DE REGENERACION MEDULAR MEDIANTE LA CELULAS MADRE ESTROMALES , proyecto de sobra conocido por todos vosotros, y en el que APINME ha puesto todos sus esfuerzos, se está retrasando sobre las fechas previstas y sobre todo cuando definitivamente van a empezar.

    El hecho de que en la reunión estuviera tanto el Equipo de investigación, como el Director de la Fundación del Hospital para la Investigación, como el Gerente del Hospital, nos permit?*a tenerlos a todos en la misma mesa y as?* que cualquier problemática se pudiera discutir y sobre todo solucionar sobre la marcha.

    As?* las cosas , se abrió la reunión explicando tanto por el Equipo de Investigación, como por los responsables del Hospital, que el tiempo medio desde que una Sala de estas caracter?*sticas se comienza a instalar hasta su puesta en funcionamiento, con todos los protocolos, controles y demás, concluyendo todo el proceso con la autorización de los técnicos del MINISTERIO DE SANIDAD, es de unos 15 MESES. Actualmente desde que la Sala Blanca de Terapia Celular aplicada a la Lesión Medular APINME, comenzó su instalación hasta que se terminó de instalar y comenzaron los protocolos de validación y homologación de los procesos a desarrollar en ella han transcurrido 18 meses. Ha habido un retraso respecto de la media de 3 meses, debido a innumerable problemas técnicos derivados de las instalaciones dependientes del hospital y que alimentan a la Sala.

    Aunque a todos los Lesionados medulares, que seguimos el proyecto, nos pueda parecer que el proyecto se retrasa y retrasa sin motivo aparente. La realizad es esta, y quizá el problema venga de que igual todos nos hicimos una previsiones algo optimistas en cuanto a plazos, que luego la realidad nos ha puesto en nuestro sitio. Y quizá nosotros fuimos los primeros en confundiros, llevados por la ilusión de comunicaros que esto empezaba ya, aunque no es menos cierto que siempre transmit?*amos lo que desde el equipo de investigación nos dec?*an.

    Bueno, al final lo importante de todo esto y lo que se concluyo en la reunión es lo siguiente:

    1.- La Sala con sus protocolos, validaciones , etc. está terminada, y la documentación se env?*a al MINISTERIO y a la AGENCIA DEL MEDICAMENTO a final de este mes de JUNIO.

    2.- Tanto el Ministerio como la Agencia tiene 3 MESES máximo, para girar visita y si todo esta OK , dar luz verde. Consta que como tanto desde la Agencia como del Ministerio, la implicación es total lo más probable es que una vez revisada la documentación durante el mes de Julio y dado que Agosto (es perdido por vacaciones), la previsiones son que en SEPTIEMBRE , si todo esta OK, cosa en la que confiamos den luz verde.

    3.- Puesto que se ha adelantado todo el tema de los 12-20 pacientes con L.M ( dorsal, completa), que se realizaran la terapia, es presumible pensar que finales de SEPTIEMBRE , primeros OCTUBRE, comenzara oficialmente el ensayo con la extracción de células a este primer paciente.

    4.- Como sabéis el tiempo de cultivo medio de las células para el posterior implante intramedular es de unas 4 SEMANAS, por lo que si todo va según lo previsto se implantar?*an en este primer paciente en NOVIEMBRE.

    Esto es todo lo que desde APINME, os podemos contar , tal cual concluimos de la reunión. Debéis entender que esto es ciencia experimental y puede estar sujeta a variables impredecibles, por lo que os rogamos entendáis que todo esto pueda suceder. También nos parece importante indicaros que este proyecto tan pionero, es la insignia actual del Hospital y que ellos por la parte que les toca está muy interesados en que todo se realice cuanto antes y poder difundirlo a bombo y platillo, por el prestigio que les dar?*a. Evidentemente no les motiva lo mismo que a nosotros que sufrimos el padecer una L.M con todas las complicaciones que conlleva, al margen del sufrimiento moral que a muchos nos supone.

    Por último indicaros que APINME, ha cumplido escrupulosamente con todos los pagos comprometidos con la Sala. Que evidentemente todo el dinero no se ten?*a por lo que para que la Sala se montara y no se retrasara mas, como sabéis y si no os lo digo, se pidió un préstamo , al cual tenemos que hacer frente con vuestras aportaciones, eventos, loter?*a, etc. Por lo que os rogamos ahora más que nunca que los que podáis continuéis ayudándonos, y podamos afrontarlo.

    Esperamos haber aclarado las dudas, y de una vez por todas haber acertado con los pronósticos para el comienzo de los ensayos, ahora solo falta que funcionen conforme a lo esperado y de verdad alcancemos el objetivo final, pero esto ya no depende de nosotros, sino de la ciencia.

    Un cordial saludo a todos, y aqu?* estamos para cuantas dudas os surjan.

  5. #25
    Been wanting to try Google Translate. It translated a name to 'Dr. Jesus Cowboy' which is my new pseudonym:


    As you know some day this past June 22, 2012, representatives of APINME (David Aviles, Frederic Crespo, and Jose Vicente Xaxi Cuines Esteva), we held an important meeting at Hospital Puerta de Hierro with the Research Team (Dr. Jesus Cowboy ), the Director of the Foundation for Biomedical Research (D. Cubero Jesus) and the Hospital Manager (D. Jorge Gomez Zamora).

    The main reason for the meeting was to learn first hand and practical way, because that CONSISTENT CLINICAL TRIALS IN THE THERAPY OF SPINAL CORD REGENERATION THROUGH stromal stem cells, well known project for you all, and which has APINME put all its efforts, is being delayed on the scheduled dates and especially when you definitely are going to start.

    The fact that the meeting was therefore the investigation team as the Director of the Foundation's Research Hospital as the Manager of the Hospital, allowing us to have them all at the same table and so any problems could be discussed and especially progress solve.

    So, opened the meeting by explaining both the research team, for those responsible for the Hospital, the average time from a room of this kind is beginning to set up their operation, with all protocols, controls and others, concluding the process with the permission of the Technical Department of Health, is about 15 MONTHS. Currently since the Clean Room Cell Therapy applied to the Spinal Cord Injury APINME, began her installation until finished installing and started validation protocols and approval processes to be developed in her 18 months have elapsed. There has been lagging behind the average of 3 months due to innumerable technical problems relating to hospital facilities dependent and fuel to the Chamber.

    Although all spinal injuries, we continue the project, it may seem that the project is delayed and delayed for no apparent reason. The Realize this is, and maybe that was a problem as we all had a somewhat optimistic forecasts in terms of time, then reality has put us on our site. And maybe we were the first to confuse you, driven by the hope to inform you that this was beginning, though not always true that what we broadcast from the research team told us.

    Well, in the end the important thing about all this and what was concluded at the meeting is as follows:

    A. - The Board with its protocols, validations, etc.. is finished, and the documentation is sent to the Ministry and the Medical Products Agency later this month of JUNE.

    2. - Both the Ministry and the Agency is 3 months maximum to rotate visit and if everything is OK, give the green light. Ground that as both the Agency and the Ministry, the implication is all the more likely is that after reviewing the documentation for the month of July and August since (is lost on holiday), the projections are that in September, if all is OK, nothing we trust the green light.

    3. - Since it has been ahead the whole issue of 12 to 20 patients with LM (dorsal, full), to be undertaken therapy, presumably thinking that the end of September, early October, the trial officially began with the extraction of cells in this first patient.

    4. - As you know the culture time between cells for subsequent intramedullary implant is about 4 weeks, so if all goes according to plan would be implemented in this first patient in November.

    This is all from APINME, I can tell, as they conclude the meeting. You must understand that this is experimental science and may be subject to unpredictable variables, so we urge you understand that all this can happen. It also seems important to point out to us that this project as a pioneer, is the current flagship of the Hospital and they by their share is very interested in that everything is done as soon as possible and to spread with great fanfare, for the prestige it would give . Obviously not what motivates them equal to us who suffer the suffering an LM with all its complications, regardless of moral suffering that many of us assumed.

    Finally indicaros that APINME, has scrupulously complied with all payments committed to the Chamber. Obviously all the money was not so for the Board will be mounted and no more delay, as you know and if I tell you, it borrowed, to which we have to deal with your contributions, events, lottery , etc. So we ask you now more than ever that you can you will continue helping us, and we can deal with it.

    We hope to have clarified the doubts, and once and for all be successful with forecasts for the first test, now we just need to work as expected and actually reach the ultimate goal, but it no longer depends on us, but of science.

    Regards to all, and here we are for such doubts will arise.

  6. #26
    Senior Member KIM's Avatar
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    Smile

    Soon good news.

  7. #27
    Quote Originally Posted by KIM View Post
    Soon good news.
    care to elaborate?

  8. #28
    Quote Originally Posted by KIM View Post
    Soon good news.
    soon, this week?
    soon, this year?

  9. #29
    Quote Originally Posted by quadfather View Post
    soon, this week?
    soon, this year?
    5 more years

  10. #30
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    like a car with a engine passed - those on the tribune said yes - the ones not on the tribune wasn't there. Wy involve in things at all? What does 5 more years mean? Stupid discussions.

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