B4711001 Stem cell transplantation in wet AMD

• Research type

  Research Study

• Full title

  PHASE 1, OPEN-LABEL, SAFETY AND FEASIBILITY STUDY OF IMPLANTATION OF PF-05206388 (HUMAN EMBRYONIC STEM CELL DERIVED RETINAL PIGMENT EPITHELIUM (RPE)LIVING TISSUE EQUIVALENT) IN SUBJECTS WITH ACUTE WET AGE RELATED MACULAR DEGENERATION AND RECENT RAPID VISION DECLINE

• IRAS ID

  96163

• Contact name

  Lyndon da Cruz

• Contact email

  lyndon.dacruz1@nhs.net

• Sponsor organisation

  Moorfields Eye Hospital NHS Foundation Trust

• Eudract number

  2011-005493-37

• Clinicaltrials.gov Identifier

  NCT01691261

• Duration of Study in the UK

  2 years, 5 months, 0 days

• Research summary

  Pfizer Global Research & Development in collaboration with University College London and Moorfields Eye Hospital are developing an advanced therapy medicinal product based on human embryonic stem cells (hESC) known as the SHEF 1 cell line. The proposed product (PF 05206388) comprises SHEF 1 cells differentiated to form Retinal Pigment Epithelium (RPE) cells fixed to a vitronectin coated polyester membrane and will be surgically implanted subrtinally using a surgical device. PF 05206388 will replace RPE in the eyes of patients with acute, declining untreatable or treatment failing wet age-related macular degeneration (AMD).
  The target population of PF-0506388 in this exploratory study is patients with wet AMD with significant recent decline in vision who are deemed ineligible for, or for whom treatment with anti VEGF therapeutic agents (e.g Lucentis) is failing.
  It is anticipated that RPE transplantation may eventually be indicated in many atrophic and neovascular macular diseases, including inherited, inflammatory and age-related wet and dry degenerations.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  GTAC194

• Date of REC Opinion

  8 May 2013

• REC opinion

  Further Information Favourable Opinion