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Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD

NCT03549299 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-10-07

No results posted yet for this study

Summary

The aim of this clinical trial is to investigate the efficacy (by monitoring neovascularization and epithelial defects) of up to four doses of the investigational medicinal product (IMP) LSC2 topically administered on the target eye of patients with LSCD. Further, safety of the IMP during and after application will be investigated (by monitoring adverse events \[AEs\]).

Conditions

  • Limbal Stem Cell Deficiency

Interventions

BIOLOGICAL

LSC2

Topical application of IMP on target eye

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Ticeba GmbH

    collaborator INDUSTRY

  • Granzer Regulatory Consulting & Services

    collaborator OTHER

  • RHEACELL GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Gerd U. Auffarth, Prof.Dr.med. · Universitäts-Klinikum Heidelberg, Kopfklinik, Heidelberg, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-04
Primary Completion
2023-09-30
Completion
2023-09-30
FDA Drug
Yes

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549299 on ClinicalTrials.gov