Trial locations: Plus current info

[rocky301]

clinical trials registry
Search of: "Advanced Cell Technology" - List Results - ClinicalTrials.gov

***All 5 injections cited below are 50,000 cells

TRIAL SITE LOCATIONS IN THE UNITED STATES

JULES STEIN:
Los Angeles, California
Principal Investigator: Steven Schwartz, MD
IRB approved for (2) eye indications

DRY AMD:ADVANCED Dry Age Related Macular Degeneration
ONE(1) dryAMD patient injected to date
Injected July 12, 2011..78 year old female...Sue Freeman

SMD Stargardt's Macular Dystrophy
3 SMD patients injected completing Cohort 1 as of Feb 6,2012
1st..Injected July 12, 2011..female in her 50's
2nd..Injected January 24, 2012..47 year old male
3rd..Injected February 6, 2012

Embryonic stem cell trials for macular degeneration: a preliminary report
for 1 dry AMD and 1 SMD, initiaL 2 patients.
THE LANCET
http://download.thelancet.com/flatco...3612600282.pdf


Bascom Palmer Eye Institute
Miami, Florida, United States
Contact: Cristy M Lage-Rodriguez, M.S., C.C.R.C 305-326-6117 CLage@med.miami.edu
Principal Investigator: Philip Rosenfeld, MD, PhD
1)dryAMD

Wills Eye Institute
Philadelphia, Pennsylvania
Principal Investigator: Carl D Regillo, MD
IRB approved for (2) eye indications
1)dryAMD
3)SMD

No Patients treated at this time
E-mail I received from Michelle Markun Research Coordinator on process/time frame
Leading Eye Institute to Participate in ACT's Embryonic Stem Cell Clinical Trial
Poster "sheltiesage" phone converstion with Michelle Markun
Leading Eye Institute to Participate in ACT's Embryonic Stem Cell Clinical Trial

TRIAL LOCATIONS OUTSIDE THE UNITED STATES:

Moorefields Eye Hospital NHS Foundation Trust
United Kingdom
London, United Kingdom,
Principal Investigator: James Bainbridge, MA MB BChir PhD FRCOpth
Currently MHRA and GTAC Approved For (1) eye indication
***
1) SMD: Stargardt's Macular Dystrophy[B]
1) Injection January 20,2012..34 year old male...Marcus Hilton

***seeking clearance for dryAMD

Aberdeen Royal Infirmary
United Kingdom
Phase 1/2 human clinical trial for Stargardt’s Macular Dystrophy (SMD)
Dr. Noemi Lois..lead investigator

__________________________________________________ _________________________
ORPHAN DRUG DESIGNATION BOTH IN THE USA AND EUROPE FOR SMD
Biological: MA09-hRPE Cellular Therapy

1) US Food and Drug Administration FDA has granted orphan drug designation for the company’s MA09-hRPE cells for use in the treatment of Stargardt’s Macular Dystrophy
2) European Medicines Agency's EMA Committee for Orphan Medicinal Products COMP has officially granted ACT's human embryonic stem cell hESC-derived retinal pigment epithelial #RPE# cells designation as an orphan medicinal product for the treatment of Stargardt's Macular Dystrophy SMD


POSSIBLE FAST TRACKING AND INCENTIVES

Granting orphan drug status makes the following advantages available to the sponsor:

(i) a 50% tax credit on the cost of clinical trials undertaken in the USA;

(ii) a period of seven years of marketing exclusivity following the Marketing Authorization;

(iii) some written recommendations provided by the FDA concerning clinical and preclinical studies; and

(iv) a fast-track procedure for the FDA to evaluate registration files.

Another orphan grants program allows researchers to compete for funding to conduct clinical trials for rare disease drugs. These grants may cover up to US$200,000 of direct costs per year for up to three years depending on the stage of the clinical study.
Advanced Cell Technology (ACTC): Possible Fast Tracking?

[brentlew]

Excellent!

When 'the' news hits, and the newbies come
alooking, this is the type of factual information
a newbie needs to see, and to have it all in
one place, Priceless!

I hope the site can handle the exponential
increase in the number of hits when news
starts being disseminated.

Feeed?

PATIENCE and Patients!

[Riddakilla]

Excellent!
I hope the site can handle the exponential
increase in the number of hits when news
starts being disseminated.

PATIENCE and Patients!

I doubt it, but when ever the site is down that means something good is going on. The past few time the site has gone down, my etrade acct. has gone up! Always looking at the bright side of things.

[rocky301]

Please, if anyone has some important additions or error corrections, let me know
so I can edit. I find myself confused at times on what location has what approvals
and who will be doing what when. E-mails I have received of late confirm I am not the
only one getting mixed up at times so that was the reason/intent of post...thanks

[davea0828]

Rocky,

Outstanding post this Saturday Morning. Everything you need in one place. Just a great summary.

Dave

[BigMike]

Please, if anyone has some important additions or error corrections, let me know
so I can edit. I find myself confused at times on what location has what approvals
and who will be doing what when. E-mails I have received of late confirm I am not the
only one getting mixed up at times so that was the reason/intent of post...thanks

This is great - thanks yet again Rocky!

CHA Biotech Co Ltd.......do they have sites approved? Maybe since they are separate, we don't want to incorporate into this. But just a thought. They're using our stuff, so whatever happens there would impact us quite a bit I would think......

As an aside, I wonder what's going on with things there......I can understand ACTC waiting for more injections, but why would CHA wait? Unless the results were so good they were hoping they could skip steps, too???? I know the Korean scientific community has taken hits of late and perhaps they prefer for "branding" purposes its better for them, too, to have the US go first? Interesting....we'll find out in the next few weeks it sounds like (hopefully).......it would take a lot of pluses on the "wait" side (considering all the pluses on the "no wait" side) for me to wait if I was CHA.....

[stockticker]

do you think adding cohort info for ph 1/2 would be helpful?

[Harlem]

Rocky--a very very big thank you!!!!!!! ---Harlem

[Peter Vaguely]

Thanks Rocky, terrific post. I am sharing with fence-sitting family and friends as well as those who are already "in." You are a great resource.

[rocky301]

This is great - thanks yet again Rocky!

CHA Biotech Co Ltd.......do they have sites approved? Maybe since they are separate, we don't want to incorporate into this. But just a thought. They're using our stuff, so whatever happens there would impact us quite a bit I would think......

As an aside, I wonder what's going on with things there......I can understand ACTC waiting for more injections, but why would CHA wait? Unless the results were so good they were hoping they could skip steps, too???? I know the Korean scientific community has taken hits of late and perhaps they prefer for "branding" purposes its better for them, too, to have the US go first? Interesting....we'll find out in the next few weeks it sounds like (hopefully).......it would take a lot of pluses on the "wait" side (considering all the pluses on the "no wait" side) for me to wait if I was CHA.....

BigMike,

I have not seen CHA on any approved trial registries whatsoever. Not doing so would
not allow any publications to recognized outlets. I have not looked in a while so I
will do so sometime today. I question whether they are in any clinical trials at this time, jmo...thanks

[rocky301]

do you think adding cohort info for ph 1/2 would be helpful?

stockticker,

I believe the info you ask about is all available at the clinicaltrials.gov links
that were provided in post...If not what you meant, let me know...thanks
Search of: "Advanced Cell Technology" - List Results - ClinicalTrials.gov

[stockticker]

Rocky, thanks for ur reply, i thot purpose of OP was to provide all info at one place having cohort and dosage info will make it complete IMO

[saxxie]

Here's Cha Biotech StemCell Therapy Site:

http://eng.chabio.com/bz_medicine2.asp

[brentlew]

Here's a suggestion.

Currently, the ACTC forum has 4 labeled sections,
with the 5th being a Miscellaneous.

How about a 5th labeled section, one exclusively
for posts like this one, with this section being
labeled 'For Newcomer's' section, or something along
those lines. They are going to come, it's only a
matter of time, and to aid them in having to sift
thru ALL this information, it's there for the newbie's
all in one place.

Just a thought!

PATIENCE and Patients!

[pacman]

Rocky, great post, thanks. You highlighted the quote from Rabin's blog below, would you please explain what it could mean?

"We are far enough along that at this point the additional waiting time will be measured only in weeks, not months."

[rocky301]

Rocky, great post, thanks. You highlighted the quote from Rabin's blog below, would you please explain what it could mean?

"We are far enough along that at this point the additional waiting time will be measured only in weeks, not months."

pacman,

Rabin would probably be the only one who could tell you what he meant since he authored the
quote. I feel it could take on many meanings and I don't spend much time trying to figure those
types of things out. If you are looking for my opinion, I read it say no more than 4 weeks which
puts us into Feb 10 timeframe. I view the next patients injected statements and the journal
publication predicted times just that, predictions. When they happen...they happen...thanks

[tarcham]

Weeks to me, means more than 2, but less than 8 - over 8 would be in the second month and thus months. It is still a guess what Gary meant - regardless it is very close relative to how long we have waited !

Rocky, great post, thanks. You highlighted the quote from Rabin's blog below, would you please explain what it could mean?

"We are far enough along that at this point the additional waiting time will be measured only in weeks, not months."

[Selluwud]

Please, if anyone has some important additions or error corrections, let me know
so I can edit. I find myself confused at times on what location has what approvals
and who will be doing what when. E-mails I have received of late confirm I am not the
only one getting mixed up at times so that was the reason/intent of post...thanks

Thanks Rocky, the facts as we know them, everything else is conjecture but oh how we dream.

[davea0828]

pacman,

Rabin would probably be the only one who could tell you what he meant since he authored the
quote. I feel it could take on many meanings and I don't spend much time trying to figure those
types of things out. If you are looking for my opinion, I read it say no more than 4 weeks which
puts us into Feb 10 timeframe. I view the next patients injected statements and the journal
publication predicted times just that, predictions. When they happen...they happen...thanks

Rocky,

You mention maybe Feb 10 timeframe. I say make it February 11th, and we will match up with Dr. Lanza's birthday.



Dave

[Actc_fan]

Rocky,

Looks like you are editing the original post with new information and have removed some. I thought you (we) had identified the SMD patient as a 26 year old female? Every source today is saying a women in her 50's.

Thanks