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  • blackmarango blackmarango Oct 23, 2011 9:37 PM Flag

    Patients #2 &3?

    What's happened to the injection schedule for patients 2 & 3?

    It's been over 3 weeks since the approval was made.

    Do you think that ACTC has injected without issuing a PR?

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    • That's good and logical and very optimistic; why spend money on trials that you may not need all at once.

    • Really? I didn't get that from your original post. BTW guess who talked about the test sites?

    • 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 least try to offset the impact by reminding people what they have going that is positive.

    • I think they said that they would not be issuing PR's for every injection. You'll just have to wait to find out the results when they are ready to release those results.

    • 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 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
      ◦Clinical monitoring
      ◦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
      Treatment: Experimental
      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

      Detailed Description:
      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.

    • they are too busy with law suit after law suit hit them lately!!!!!!!!!!!


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