Yes, I'd assume they already proceeded, since they had a decent pool to chose from when the first patients were chosen. And now enough time has passed that the testing, and immuno drugs have probably already been given/completed.
Would be nice to get a PR, in light of all the bad PR...at least try to offset the impact by reminding people what they have going that is positive.
I suppose that not issuing a PR for each injection is the most likely explanation.
GERN issued a PR for the first injection and then went more or less silent. We'd find out in a conference paper or CC that another patient had been injected. The information simply wasn't very current.
You got it Bio...my prev. post came from the National Institutes of Health, could not get the header in as the report is too lengthy for this board...the original question is "what happened to the schedule?"...well, this is it.
Sub-retinal Transplantation of hESC Derived RPE(MA09-hRPE)Cells in Patients With Stargardt's Macular Dystrophy
This study is currently recruiting participants.
Verified on May 2011 by Advanced Cell Technology
First Received on April 28, 2011. Last Updated on May 16, 2011 History of Changes
Sponsor: Advanced Cell Technology
Information provided by: Advanced Cell Technology
ClinicalTrials.gov Identifier: NCT01345006
This is a safety and tolerability tria
Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis
MedlinePlus related topics: Macular Degeneration
U.S. FDA Resources
Further study details as provided by Advanced Cell Technology:
Primary Outcome Measures:
•The safety and tolerance of transplantation of hESC-derived RPE cells MA09-hRPE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
The transplantation of hESC-derived RPE cells MA09-hRPE will be considered safe and tolerated in the absence of:
◦Any grade 2 (NCI grading system) or greater adverse event related to the cell product
◦Any evidence that the cells are contaminated with an infectious agent
◦Any evidence that the cells show tumorigenic potential
•Safety Assessments [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
◦Adverse Event and Serious Adverse Event assessment
◦Serial vital signs
◦Clinical laboratory tests
◦Directed ophthalmological monitoring
◦Monitoring of RPE cells acceptance/integrity/rejection
◦Monitoring of local and systemic infection
◦Monitoring of tumorigenic cell transformation
Secondary Outcome Measures:
•Evidence of successful engraftment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Evidence of successful engraftment will consist of:
◦Structural evidence (OCT imaging, fluorescein angiography, autofluorescense photography, slit-lamp examination with fundus photography) that cells have been implanted in the correct location
◦Electroretinographic evidence (mfERG) showing enhanced activity in the implant location
Estimated Enrollment: 12
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Patients will undergo subretinal injection of MA09-hRPE
Intervention: Biological: MA09-hRPE Cellular therapy Biological: MA09-hRPE Cellular therapy
Cohort 1 50,000 cells
Cohort 2 100,000 cells
Cohort 3 150,000 cells
Cohort 4 200,000 cells
This study is a Phase I/II, open-label, non randomized, sequential, multi-center clinical trial. There will be 3 cohorts, each consisting of 3 patients. The enrolled cohorts will be as follows:
•Three SMD patients- 50,000 MA09-hRPE cells transplanted
•Three SMD patients- 100,000 MA09-hRPE cells transplanted
•Three SMD patients- 150,000 MA09-hRPE cells transplanted
•Three SMD patients- 200,000 MA09-hRPE cells transplanted
Patients will be enrolled sequentially, and within each cohort of 3 patients, each patient's clinical course over the first 6 weeks following cell transplantation will be reviewed by an independent (DSMB) before enrollment is opened for the next 2 patients. A full safety assessment of all 3 patients in each cohort will be made by the DSMB when the 3rd patient in each cohort completes 4 weeks of follow-up, and before the first patient in the next cohort receives a cell transplant.
Each cohort will be enrolled sequentially in turn.
The day of the cell implantation will be Day 0, and patients will remain in the study until the last visit at 12 months.