Allogeneic ABCB5-positive Limbal Stem Cells for Treatment of LSCD

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Limbal Stem Cell Deficiency

In brief

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 \[AEs\]).

Key facts

Study ID

NCT03549299

Run by

RHEACELL GmbH & Co. KG

People needed

16

Starts

2019-07-04

Expected to finish

2023-09-01

Last updated by the study team

2022-10-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Compromised eyelid mobility and/or symblepharon; patient can be re-screened after appropriate treatment
• Presence of eyelid malposition; patient can be re-screened after appropriate treatment
• Active local ocular or systemic infection and/or inflammation. Patient can be re-screened after infection and/or inflammation is resolved.
• Tumor diseases or history of tumor disease
• Active ocular neoplastic disease (exclusion will be based on investigator's assessment)
• Corneal erosion or ulcer is bigger than 4 mm2; corresponding to less than 95% of continuous corneal epithelium. Patient can be re-screened after erosion or ulcer is resolved (≤ 4 mm2).
• Positive for human immunodeficiency virus (HIV) 1 and/or 2 (diagnosed by serologic testing)
• Clinically significant or unstable concurrent disease or other clinical contraindications to stem cell transplantation
• History of glaucoma
• Contraindications to trial related procedures/substances including
• The surgical procedure (e.g. removing of the conjunctival pannus)
• Contact lens complications due to contact lens use in the proposed trial (based on the Efron Grading scale for standard clinical reference for contact lens complications)
• Tear secretion deficiency determined by Schirmer's test
• Allergy, sensitivity or intolerance to components/excipients of the IMP/ per protocol pre-planned concomitant medications
• Conjunctival scarring with fornix shortening
• General anesthesia (in case general anesthesia is required) or local anesthesia
• Immunosuppression (being mandatory concomitant therapy)
• Intraocular pressure (IOP) of ≥30 mm Hg
• History or clinical signs of stroke or transient ischemic attacks
• Active or suspected ocular or periocular infections
• Active or suspected intraocular inflammation
• Further clinical contraindications to IMP application (exclusion will be based upon investigator's judgment)
• Current or previous (within 30 days of enrollment) treatment with another IMP, or participation and/or under follow-up in another clinical trial
• Previous participation in this clinical trial (except screening failure due to inclusion criterion 2 and/or exclusion criterion 1 and/or 2 and/or 3 and/or 6)
• Known abuse of alcohol, drugs, or medicinal products

Where it is running

• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• Universitäts-Klinikum Köln, Augenklinik — Cologne, Germany
• Universitäts-Klinikum Heidelberg, Kopfklinik — Heidelberg, Germany
• Universitäts-Klinikum Jena, Augenklinik — Jena, Germany
• Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik — Mainz, Germany

Full record on ClinicalTrials.gov

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