A Phase 1/2 interventional study of Single Dose and Double Dose in Chronic Conjunctivitis, Stevens-Johnson Syndrome and Lyell Syndrome, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Active, not recruiting at 8 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Phase 1/2, Interventional, and Treatment
A phase IIa, open label, non controlled clinical trial to assess the feasibility and safety of allogeneic adipose-derived mesenchymal stem cells (ASC) in the treatment of cicatricial conjunctivitis associated with Lyell's syndrome, Stevens-Johnson's syndrome and mucous membrane pemphigoid with ocular involvement
A multicentre, nationwide clinical trial will be performed. 20 patients fulfilling eligibility criteria will be included in two different dose level cohorts: the first 10 patients included will receive a single cell application and the remainder 10 will be administered 2 cell applications separated by 15 days.
The investigational drug consists of locally administered, expanded, allogeneic adipose-derived adult mesenchymal stem cells (ASCs), at a dose of 5 million cells per ml (0,5 ml to be infused per quadrant)
Study cronogram: recruitment is estimated to take 8 months, and follow-up period will be 12 months.
40 studies on the registry are indexed under Stevens-Johnson Syndrome; 8 are open to participants now.
This study's enrollment of 20 is close to the median of 20 across 24 interventional studies indexed under Stevens-Johnson Syndrome.
Browse Stevens-Johnson Syndrome studies →Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 76 studies on the registry; 27 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells
Drug: Single Dose
Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells at day 0 and 12,5 million cells at day 14
Drug: Double Dose
Single Dose: Administration of 12,5 million allogeneic mesenchymal stem cells derived from adipose tissue by subcnjunctival injection and topical conjunctival injection.
Repetead Dose: Administration of 2 doses, separated by 14 days, of 12,5 million allogeneic mesenchymal stem cells derived from adipose tissue by subcnjunctival injection and topical conjunctival injection.
Percentage of complications
Percentage of complications related to anesthesia, administration of investigational medicinal product and postoperative period.
Time frame: Through study completion, an average of 3 years
Signs improvement
Changes from baseline in scarring conjunctivitis rating scale
Time frame: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Symptom improvement
Changes from baseline in Ocular Surface Disease Index (OSDI) questionnaire (0-48). The lower the rate obtained in the score, better the outcome.
Time frame: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Visual acuity improvement
Changes from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) (0-1,2). The higher the rate obtained in the score, better the outcome.
Time frame: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
changes in quality of life
Changes from baseline using the specific National Eye Institute-Visual Function Questionnaire 25 (NEI-VFQ-25) (0-100). The value of 0 is the lowest and 100 the best possible
Time frame: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
evolution of the conjunctival flora
variation in the number and type of microorganisms in the conjunctival exudates, performing cultures and PCR herpes viridae
Time frame: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2022 to primary completion in Jun 2024, 19 months.
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This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz