Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conju… (NCT05520086) | Clinical Trial Compass
UnknownPhase 1/2
Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conjuntivitis.
Spain20 participantsStarted 2022-11-11
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. Medical or psychiatric illness of any kind that, in the opinion of the investigator, may be a reason for exclusion from the study.
✕. Congenital or acquired immunodeficiencies.
✕. Major surgery or serious trauma of the subject in the semester prior to signing the IC.
What they're measuring
1
Percentage of complications
Timeframe: Through study completion, an average of 3 years