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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05520086
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nicolás Alejandre Alba
Principal Investigator Affiliation	Hospital Fundación Jiménez Diaz
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Active, not recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Conjunctivitis, Stevens-Johnson Syndrome, Lyell Syndrome, Pemphigoid

Additional Details

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.

Arms & Interventions

Arms

Experimental: Single dose Allogenic Adiposse derived mesenchimal stem cells

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

Experimental: 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

Interventions

Drug: - Single Dose

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Instituto Oftalmológico Fernández - Vega, Oviedo, Asturias, Spain

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Address

Instituto Oftalmológico Fernández - Vega

Oviedo, Asturias, 33012

Hospital Universitario de Cruces, Barakaldo, Bizkaia, Spain

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Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903

Hospital General La Mancha Centro, Alcázar De San Juan, Ciudad Real, Spain

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Hospital General La Mancha Centro

Alcázar De San Juan, Ciudad Real, 13600

Hospital La Arruzafa, Córdoba, Spain

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Hospital La Arruzafa

Córdoba, , 14012

Madrid, Spain

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Hospital General Universitario Gregorio Marañon

Madrid, , 28007

Madrid, Spain

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Hospital Universitario Fundación Jiménez Diaz

Madrid, , 28040

Hospital Universitario La Paz, Madrid, Spain

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Hospital Universitario La Paz

Madrid, , 28046

Valladolid, Spain

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Address

Hospital Clínico Universitario de Valladolid

Valladolid, , 47003

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