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.

FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE0 个研究点目标入组 20 人开始时间: 2022年2月11日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•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 .
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•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

发起方

FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE