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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain
Hospital General La Mancha Centro
Alcázar de San Juan, Ciudad Real, Spain
Instituto Oftalmológico Fernández - Vega
Oviedo, Principality of Asturias, Spain
Hospital La Arruzafa
Córdoba, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario Fundación Jiménez Diaz
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
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
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