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

NCT05520086 | Unknown Phase 1

• 1 other identifier: CELOPHIN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Chronic Conjunctivitis; Stevens-Johnson Syndrome; Lyell Syndrome; Pemphigoid

Outcome Measures

Primary Outcomes (1)

• Percentage of complications

  Percentage of complications related to anesthesia, administration of investigational medicinal product and postoperative period.

  Through study completion, an average of 3 years

Secondary Outcomes (5)

• Signs improvement

  At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks

• Symptom improvement

  At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks

• Visual acuity improvement

  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

  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

  At 7 days (and 21 days in the 2-dose group), 4 weeks, 12 weeks, 24 weeks and 52 weeks

Study Arms (2)

Single dose Allogenic Adiposse derived mesenchimal stem cells

EXPERIMENTAL

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

Drug: Single Dose

Double dose Allogenic Adiposse derived mesenchimal stem cells

EXPERIMENTAL

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

Interventions

Single Dose DRUG

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

Single dose Allogenic Adiposse derived mesenchimal stem cells

Double Dose 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.

Double dose Allogenic Adiposse derived mesenchimal stem cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years of age.
• 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)
• 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
• Consent to participate and signature of the informed consent

You may not qualify if:

• Signs of active infection on the ocular surface.
• History of neoplasms in the last 5 years. except for epithelial basal or squamous cell carcinoma
• Allergy to local anesthetics
• Patients who have participated in another clinical trial with medication during the 90 days prior to signing the IC
• Congenital or acquired immunodeficiencies.
• Major surgery or serious trauma of the subject in the semester prior to signing the IC.
• Pregnant or lactating women.
• Impossibility or refusal to carry out the follow-up required in the study by the patient

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (8)

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

Location

Hospital General La Mancha Centro

Alcázar de San Juan, Ciudad Real, 13600, Spain

Location

Instituto Oftalmológico Fernández - Vega

Oviedo, Principality of Asturias, 33012, Spain

Location

Hospital La Arruzafa

Córdoba, 14012, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Fundación Jiménez Diaz

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

MeSH Terms

Conditions

Stevens-Johnson Syndrome; Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Autoimmune Diseases

Study Officials

• Nicolás Alejandre Alba

  Hospital Fundación Jiménez Diaz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 29, 2022
• Study Start: November 11, 2022
• Primary Completion: June 11, 2024
• Study Completion: November 11, 2024
• Last Updated: July 8, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8)