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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2024-11-11

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Conjunctivitis Stevens-Johnson Syndrome Lyell Syndrome Pemphigoid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

2 consecutive cohorts will be included in order of recruitment. the first 10 patients will receive 1 single dose and the second 10 patients will receive 2 doses separated by 15 days

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single dose Allogenic Adiposse derived mesenchimal stem cells

Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells

Group Type EXPERIMENTAL

Single Dose

Intervention Type DRUG

Single Dose: Administration of 12,5 million allogeneic mesenchymal stem cells derived from adipose tissue by subcnjunctival injection and topical conjunctival injection.

Double dose Allogenic Adiposse derived mesenchimal stem cells

Allogenic Adiposse derived mesenchimal stem cells (MSC) Dose: 12,5 million cells at day 0 and 12,5 million cells at day 14

Group Type EXPERIMENTAL

Double Dose

Intervention Type DRUG

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.

Interventions

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Single Dose

Single Dose: Administration of 12,5 million allogeneic mesenchymal stem cells derived from adipose tissue by subcnjunctival injection and topical conjunctival injection.

Intervention Type DRUG

Double Dose

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No