Phase IIa Multicenter Clinical Trial to Determine the Feasibility and Safety of the Use of Adipose-derived Mesenchymal Stem Cells (ASC) in the Treatment of Patients With Cicatricial Conjunctivitis Associated With Lyell's Syndrome, Stevens-Johnson Syndrome and Pemphigoid of the Mucous Membranes With Ocular Involvement.

Status: Unknown
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital General La Mancha Centro
Alcázar De San Juan
Hospital Universitario de Cruces
Barakaldo
Hospital La Arruzafa
Córdoba
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario Fundación Jiménez Diaz
Madrid
Hospital Universitario La Paz
Madrid
Instituto Oftalmológico Fernández - Vega
Oviedo
Hospital Clínico Universitario de Valladolid
Valladolid
Time Frame
Start Date: 2022-11-11
Completion Date: 2024-11-11
Participants
Target number of participants: 20
Treatments
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
Sponsors
Leads: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators: Effice Servicios Para la Investigacion S.L.

This content was sourced from clinicaltrials.gov

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