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Stem Cell Therapy
LSC2; 7.5 x 10^4 cells for Limbal Stem Cell Deficiency
Phase 1 & 2
Waitlist Available
Led By Gerd U. Auffarth, Prof.Dr.med.
Research Sponsored by RHEACELL GmbH & Co. KG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with secondary bilateral or unilateral LSCD (injury that caused LSCD at least 6 months prior to inclusion)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, 2, 3, 4, 5, 6, 7, 12, month 6 and 12
Awards & highlights
Study Summary
This trial is testing a new medicine for a eye disease called LSCD. They will monitor how well the medicine works and if it is safe.
Eligible Conditions
- Limbal Stem Cell Deficiency
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a long-lasting injury to your eyes that occurred at least 6 months ago, causing damage to both or one of your corneas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 1, 2, 3, 4, 5, 6, 7, 12, month 6 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, 2, 3, 4, 5, 6, 7, 12, month 6 and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of adverse event (AE) occurrence
Response rate at 12 months after IMP application
Secondary outcome measures
Corneal opacity
Epithelial defects
Neovascularization
+10 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: LSC2; 8.0 x 10^5 cellsExperimental Treatment1 Intervention
Single dose of LSC2, 8.0 x 10^5 cells per patient
Group II: LSC2; 7.5 x 10^4 cellsExperimental Treatment1 Intervention
Single dose of LSC2, 7.5 x 10^4 cells per patient
Group III: LSC2; 3.0 x 10^5 cellsExperimental Treatment1 Intervention
Single dose of LSC2, 3.0 x 10^5 cells per patient
Group IV: LSC2; 1.2 x 10^6 cellsExperimental Treatment1 Intervention
Single dose of LSC2, 1.2 x 10^6 cells per patient
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Who is running the clinical trial?
RHEACELL GmbH & Co. KGLead Sponsor
9 Previous Clinical Trials
460 Total Patients Enrolled
FGK Clinical Research GmbHIndustry Sponsor
50 Previous Clinical Trials
6,267 Total Patients Enrolled
1 Trials studying Limbal Stem Cell Deficiency
Ticeba GmbHIndustry Sponsor
7 Previous Clinical Trials
312 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What sort of participants are the most suitable for this research project?
"This clinical trial is seeking individuals, aged 18 to 85, suffering from limbal stem cell deficiency (lscd). A total of 16 patients are being enrolled in this study."
Answered by AI
Are there open slots available for individuals to join this experiment?
"The clinical trial registry shows that this particular study has not been actively enrolling patients since October 6th 2022. Despite its inactivity, there are still six other trials recruiting individuals for their research."
Answered by AI
Does this research accept participants aged 50 or older?
"Individuals who are 18 years of age or older, but younger than 85 years old can participate in this research."
Answered by AI
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