I really dont understand the hold up. "results from china"? Did Geron or Invivo or Miami project have results from china to give to the FDA? And i know you are going to say funding. But does anyone even know how much has or still needs to be funded? All i hear is "we need 2 million, or about 100k per patient". Sooo still need the full 2 million or has 1/4 of it been raised? You dont owe anyone anything, and i greatly appreciate the work you are doing, but something feels missing and not complete or in the dark.
We are still hoping to get that trial going in Brackenridge Hospital in Texas. However, much depends whether we are able to find appropriate principal investigators for that trial.
In the meantime, we are planning to start a clinical trial in New Jersey.
pr when it will start ?
and clinical trial phases 2 austin is abandoned?
Let me fill in some of the "dark" for you. I usually don't like to complain or talk about the work that we do but it might help for me to explain what we have to do to get these trials going.
We are applying for an IND (Initial New Drug/Device application) to do a phase II and a phase III trial in the U.S. You don't get these approved until you have submitted all safety and other data from phase I/II trials. Geron, In Vivo, and Miami Project were/are phase I trials to assess safety of their therapies. To get phase II and phase III approval, you have to submit all the safety and efficacy data that you have collected to date. The key to fast approval is having all the data that the FDA needs to approve an application. I hope that we can get ours much faster because we have human data from the ChinaSCINet.
We have been waiting for our 6 month data from the phase II trial in China. Our teams are now out in the field, travelling to the patients' homes to examine them. It takes time to enter and validate the data against paper records and do the analysis. IND's are not not just ten-page applications. IND applications involve thousands of pages of safety and efficacy data. It takes drug companies with dozens of experienced regulatory staff many months to compile one IND application. I plan to spend Christmas and New Years working on this and hope to submit the IND to the U.S. FDA and other regulatory agencies before the end of January.
We are working hard on fundraising. I submitted a grant to the DOD For the UCBMC+lithium±Cethrin phase II in New Jersey but it did not make the final cut. I am talking to foundations and companies. We are collecting through JustADollarPlease.Org. We need to raise $6.4 million for the Phase III trial in the U.S, $2.4 million for the Phase II in New Jersey, $2.1 million for the Phase II in Brackenridge, $1.4 million in Hong Kong for ChinaSCINet, and $1.2 million in India for SCINetIndia trial. We are planning fundraisers with Boyd Melson in New York, as well as a televised fundraiser in Hong Kong. Details will be posted as soon as we know.
I understand your impatience. However, please put what we are trying to do in context. Geron took 4 years to get their first IND approved by the FDA in the U.S. They did not complete their phase I trial. Both In Vivo Therapeutics and Miami Project have not yet received approval of their IND applications for Phase I trials. Stem Cell Inc. is doing a phase I trial in Switzerland and NeuralStem has been doing phase I trials on ALS in Atlanta for the past year. Novartis has done phase I/II studies of Nogo antibody over the last 5 years. Each spent many millions of dollars but none are even close to Phase III.
By comparison, since 2006, ChinaSCINet has completed three clinical trials (one observation trial, one phase I lithium trial, and one phase II lithium trial). We are doing a multicenter phase II trial (assessing increasing doses of umbilical cord blood mononuclear cells, combined with methylprednisolone and lithium). We are planning a global phase III trial in China, U.S., Norway, and India for 2013. We are applying to regulatory authorities and raising money for clinical trials in multiple countries. Trial costs are supported by donations from people, Stemcyte, and government grants.
We are doing all of this with only three paid staff in Hong Kong and two part-time staff at Rutgers. The rest are volunteers, like myself. Most of the people who are doing these trials, including the doctors and nurses who actually run the trials, have other full-time jobs to do. I am incredibly proud and profoundly grateful to our doctors and nurses in Hong Kong and Kunming for their hard work to make these trials a reality. I am also humbled by the service of the people who have volunteered their bodies for these clinical trials. And, of course, I thank the thousands of people who have raised money and donated to these trials.
Last edited by Wise Young; 12-08-2012 at 08:52 AM.
Professor in france there is no way to mount a network of clinical trials?
if the phase I/II in China is not indicating any significant functional recovery (as it seems, but i give you the benefit of the doubt), why would you waste time and money doing another phase I/II in the US?
I would skip doing UCB + Li in the US and work hard to get something more promising ready ASAP for clinical trials.
In God we trust; all others bring data. - Edwards Deming