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Limbal Stem Cell Deficiency - Healing Genes
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Limbal Stem Cell Deficiency

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Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD

An Interventional, Open-label, Multicenter Phase I/IIa Clinical Trial to Investigate the Safety and Efficacy of Ascending Doses of Allogeneic ABCB5-positive Limbal Stem Cells (LSC2) for the Treatment of Limbal Stem Cell Deficiency (LSCD)


Phase 1 / 2

DESCRIPTION:

Researchers at the Massachusetts Eye and Ear Infirmary are recruiting Limbal Stem Cell Deficiency patients to participate in a trial of an investigatory treatment that inserts donor  limbal stem cells that are ABCB5-gene positive (from corneal rims of cadaveric donors, expanded in a lab).

The treatment only requires application of the investigational product, called LSC2, to the target eye of the patient during an eye surgery to remove the conjunctival pannus under local or general anesthesia. Patients will be followed up for efficacy for 1 year and for one follow-up visit at month 24 post treatment.


PATIENT MUST:

  • Be 18 to 85 years of age
  • Have secondary bilateral or unilateral LSCD (injury that caused LSCD at least 6 months prior to inclusion)
  • Not be pregnant

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Application of the investigational product, called LSC2, to the target eye of the patient during an eye surgery to remove the conjunctival pannus under local or general anesthesia.
  3. Patients will be followed up for efficacy for 1 year and for one follow-up visit at month 24 post treatment.

LOCATIONS & CONTACTS:
The study site is at the Massachusetts Eye and Ear Infirmary in Boston, MA (Map) and international locations.

Contacts:
Christoph Ganss, Dr.  |  +49 6221 71833 ext 0            (international)  |  [email protected]
Kathrin Dieter  |  +49 6221 71833 ext 0  (international)  |  [email protected]
 
SPONSORS
RHEACELL GmbH & Co. KG
FGK Clinical Research GmbH
Ticeba GmbH
Granzer Regulatory Consulting & Services
 
Or go online:
https://clinicaltrials.gov/show/NCT03549299

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