UnknownPhase 1/2

Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD

United States, Germany16 participantsStarted 2019-07-04

Plain-language 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 \[AEs\]).

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female patients aged 18 to 85 years
. Patients with secondary bilateral or unilateral LSCD (injury that caused LSCD at least 6 months prior to inclusion)
. Neovascularization: Vessel penetration of at least 2 quadrants, with central cornea involved
. Patients understand the nature of the procedure and are providing written informed consent prior to any clinical trial procedure
. Women of childbearing potential must have a negative blood pregnancy test at Visit 1
. Women of childbearing potential must be willing to use highly effective contraceptive methods during the course of the clinical trial

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response rate at 12 months after IMP application

Timeframe: Month 12

Assessment of adverse event (AE) occurrence

Timeframe: Up to 24 months.

Trial details

NCT IDNCT03549299

SponsorRHEACELL GmbH & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09

View on ClinicalTrials.gov More Limbal Stem Cell Deficiency trials