Overview

Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conjuntivitis.

Status:
Not yet recruiting

Trial end date:
2024-02-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborator:

Effice Servicios Para la Investigacion S.L.

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 with insufficient disease control or
inaceptable toxicity or impossibility to administer usual care treatments (according
to physician or patient criteria)

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

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