Cicatricial conjunctivitis associated with Lyell's syndrome, Stevens-Johnson syndrome and mucous membrane pemphigoid with ocular involvement.
Conditions
Sponsors
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women over 18 years of age. 2. Diagnosis of ocular pemphigoid in Foster stages I-IIcIIIb (2) or diagnosis of recurrent chronic or episodic inflammation accompanied by cicatricial conjunctivitis of the mucous membranes with ocular involvement after the acute phase of Stevens-Johnson Syndrome or Lyell Syndrome . 3. In the case of women of childbearing age, who are willing to use an effective contraceptive method during the period of participation in the study 4. Consent to participate and signature of the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Signs of active infection on the ocular surface. 2. History of neoplasms in the last 5 years. except for epithelial basal or squamous cell carcinoma 3. Allergy to local anesthetics 4. Patients who have participated in another clinical trial with medication during the 90 days prior to signing the IC 5. Medical or psychiatric illness of any kind that, in the opinion of the investigator, may be a reason for exclusion from the study. 6. Congenital or acquired immunodeficiencies. 7. Major surgery or serious trauma of the subject in the semester prior to signing the IC. 8. Pregnant or lactating women. 9. Impossibility or refusal to carry out the follow-up required in the study by the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of the administration of allogenic mesenchymal cells derived from adipose tissue in diabetic patients with critical ischemia of the lower limbs.;Secondary Objective: -To evaluate the preliminary efficacy of the treatment. - To evaluate the quality of life after the administration of the treatment. - To evaluate immunological changes;Primary end point(s): According to the primary objective of the study, the following variables are defined: o Percentage and type of complications arising from treatment: o Complications during anesthesia. o Complications during cell implantation. o Peri and postoperative complications.;Timepoint(s) of evaluation of this end point: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12w, 24w and 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At 7 days (and 21 days in the 2-dose group), 4 weeks, 12w, 24w and 52 weeks;Secondary end point(s): -Evaluate the preliminary efficacy of the treatment in terms of: o Improvement of signs (scarring conjunctivitis rating scale) o Symptom improvement (OSDI questionnaire) o VA improvement (EDTRS) -Assess the changes in quality of life with respect to baseline using the specific NEI-VFQ questionnaire 25 -Determine the evolution of the conjunctival flora of patients after being treated by applying ASC to the ocular surface and evaluate the effect of the treatment (to see if there is any type of immunomodulation) | — |
Countries
Spain
Contacts
Public ContactCLINICAL RESEARCH UNIT
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Outcome results
None listed