Keratopathy associated with bilateral limbic insufficiency.
Conditions
Interventions
Product Name: Suspensión de células madre mesenquimales adultas derivadas de tejido adiposo
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Suspensión de células madre mesenquimales a
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 .- Over 18 years old in good general health, according to data from the clinical history and physical examination. 2 .- Previous diagnosis of bilateral IL. 3 .- Have chronic keratopathy under the following conditions: Confimación of IL through impression cytology Repeated failure of standard treatments for this condition 4 .- Signing of 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 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 .- Do not meet any criteria for inclusion 2 .- History of malignancy within the last 5 years. 3 .- Allergy to local anesthetics 4 .- Patients who have participated in other studies during the 90 days prior to their inclusion. 5 .- Tacrolimus or cyclosporine administration in the 4 weeks prior to cell therapy. 6 .- Medical or psychiatric illness of any kind, according to the investigator, may be a reason for exclusion from the study. 7 .- Subjects with congenital or acquired immunodeficiencies. Syphilis, Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion. 8 .- Major surgery or major trauma of the subject in the previous semester. 9 .- Pregnant or lactating women.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As part of assessing the status of patients quality of life a SF-36 test will be filled out and the nonexistence of long-term adverse effects will be recorded as measured by the non-recurrence of pain, conjunctivalization, ulcers and corneal epithelial neovascularization, after 1 year from the implant. Both studies will be conducted by clinical investigators of the trial, if there is no agreement in the diagnosis an expert ophthalmologist from outside of the study will be consulted.;Timepoint(s) of evaluation of this end point: after 1 year from the implant | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility and safety of autologous ASC to treat keratopathy associated with bilateral limbic insufficiency.;Secondary Objective: To evaluate changes in quality of life of treated patients. To determine the direct evolution of patients after being treated by applying ASC in the ocular surface;Timepoint(s) of evaluation of this end point: at the 3-month implant and follow-up year;Primary end point(s): The evaluation of feasibility and safety of the study will be made once the patient has received treatment at 3-month implant and follow-up year. We define that the process is safe when development and monitoring of the trial has not produced any adverse event that may be related to the proposed therapy in the trial. All clinical adverse events during follow-up will be collected at the same time that the clinical evaluation. The main objective will be assessed the cumulative incidence of adverse effects attributed to therapy in the study. | — |
Countries
Spain
Contacts
Public ContactUnidad de Terapia Celular
Fundación para la Investigación Biomédica del Hospital
Outcome results
None listed