ChinaSCINet Update - Page 113

Jim · 09-08-2012, 02:36 PM

fti,

The Phase I & II ChinaSCINet trials were done at the Kunming Army General Hospital under the leadership of Dr. Hui Zhi. She recently had to retire from the Army because of her age and has moved to, I believe, a brand new private hospital to continue the trials there. Because it is a new facility, they have not yet been granted GCP status. Hopefully it will happen soon.

havok · 09-08-2012, 02:59 PM

Quote:

Originally Posted by Wise Young

We have not yet made that determination. In order to be eligible to be center for our trials, the hospital must be GCP (Good Clinical Practice) qualified by the sFDA (the Chinese state Food and Drug Administration. The requirements are quite onerous and the sFDA takes a long time to give GCP certification. So, we are not sure whether they will be qualified by next year. Wise.

So does this mean that phase III trials in china are at a standstill for now?

Lyerly · 09-08-2012, 04:04 PM

Does the delay in China impact the timing of US ones? Is there any idea of when they will start or a timeline or a goal? Specifically the one at Kessler?

Jim · 09-08-2012, 09:44 PM

There is no delay in the China trials, please don't make assumption because of what others post.

The data from the Phase II ChinaSCINet will be available in November. This data will be used to apply to the U.S. FDA for approval. Projected start date is mid 2013, assuming the all the funds are raised. We have a lot of work to do.

kivi66 · 09-08-2012, 10:52 PM

Jim, you are like an island of stability in a stormy ocean, good job. And it is interesting, what kind of signal will give your beacon in November.

fti · 09-09-2012, 07:03 AM

thank you very much for the responses professor young and jim

the queen mary hospital of hong kong make part of the phase 3 of clinical trials in 2013?

Wise Young · 09-10-2012, 09:46 PM

Quote:

Originally Posted by havok

So does this mean that phase III trials in china are at a standstill for now?

Havok,

No, it means that we are working very hard to get all the pieces into place for a successful application for a phase III trial in China. We have to start processing the cells in China, negotiate with centers to establish research contracts for the trial, and raise the money for the trial. A fundraiser is being planned. There are lots of meetings.

Wise.

Wise Young · 09-10-2012, 09:47 PM

Quote:

Originally Posted by fti

yet he was qualified for the phases 2 ?

GCP certification is awarded to hospitals, not doctors. This is a new hospital. Wise.

fti · 09-19-2012, 12:52 PM

Quote:

Originally Posted by fti

thank you very much for the responses professor young and jim

the queen mary hospital of hong kong make part of the phase 3 of clinical trials in 2013?

an answer please professor

Wise Young · 09-19-2012, 06:45 PM

Quote:

Originally Posted by fti

an answer please professor

fti, we have not yet chosen the centers. Wise.

09-08-2012, 02:36 PM	#1121
Jim Administrator Join Date: Jan 2002 Location: NJ Shore Posts: 7,183	fti, The Phase I & II ChinaSCINet trials were done at the Kunming Army General Hospital under the leadership of Dr. Hui Zhi. She recently had to retire from the Army because of her age and has moved to, I believe, a brand new private hospital to continue the trials there. Because it is a new facility, they have not yet been granted GCP status. Hopefully it will happen soon. __________________ . . . . SCINetUSA Clinical Trial Support Squad Member Please join me and donate a dollar a day at JustADollarPlease.org and copy and paste this message to the bottom of your signature. You can also support the SCINetUSA clinical trials by buying or helping to sell bracelets from SCIBracelets.com Raise money for SCINetUSA just by searching the Internet with http://www.goodsearch.com/ or shopping online with http://www.GoodShop.com (R.U. Foundation, Piscataway NJ)

09-08-2012, 09:44 PM	#1124
Jim Administrator Join Date: Jan 2002 Location: NJ Shore Posts: 7,183	There is no delay in the China trials, please don't make assumption because of what others post. The data from the Phase II ChinaSCINet will be available in November. This data will be used to apply to the U.S. FDA for approval. Projected start date is mid 2013, assuming the all the funds are raised. We have a lot of work to do. __________________ . . . . SCINetUSA Clinical Trial Support Squad Member Please join me and donate a dollar a day at JustADollarPlease.org and copy and paste this message to the bottom of your signature. You can also support the SCINetUSA clinical trials by buying or helping to sell bracelets from SCIBracelets.com Raise money for SCINetUSA just by searching the Internet with http://www.goodsearch.com/ or shopping online with http://www.GoodShop.com (R.U. Foundation, Piscataway NJ)

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09-08-2012, 04:04 PM	#1123
Lyerly Senior Member Join Date: Apr 2010 Location: Texas Posts: 205	Does the delay in China impact the timing of US ones? Is there any idea of when they will start or a timeline or a goal? Specifically the one at Kessler?

09-08-2012, 10:52 PM	#1125
kivi66 Senior Member Join Date: Nov 2001 Posts: 388	Jim, you are like an island of stability in a stormy ocean, good job. And it is interesting, what kind of signal will give your beacon in November.

09-09-2012, 07:03 AM	#1126
fti Senior Member Join Date: Dec 2005 Posts: 473	thank you very much for the responses professor young and jim the queen mary hospital of hong kong make part of the phase 3 of clinical trials in 2013?