Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT)

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Unknown; Phase 2

Conditions: Keratopathy

Treatments: Drug: Expanded adipose-derived stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01808378

2010-024328-53 (EudraCT Number)

HULPOFT-2010-01

Details and patient eligibility

About

Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated keratopathy

Full description

Intralesional use by inject of adipose derived stem cells

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. -Signed informed consent

2. -Previously diagnosed bilateral limbic obstruction

3. -Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination

4. -Suffering chronic keratopathy accomplishing the following criteria:

   • Confirmed limbic obstruction with an impression cytology
   • Repeated usual treatment failure for this pathology

Exclusion criteria

1. -Having suffered a neoplasia in the previous 5 years
2. -Local anesthesia allergies
3. -Patients having participate in any other study in the previous 90 days to the inclusion
4. -Patients on medication with tacrolimus or cyclosporine in the 4 previous week to the cellular therapy
5. -Any medical or psychiatric illness that, in the investigator opinion, could suppose a reason for the study exclusion
6. -Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
7. -Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
8. -Patients who have suffering major surgery or severe trauma in the prior 6 months
9. -Pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Autologous Stem Cells

Experimental group

Description:

Autologous expanded adipose-derived stem cells

Treatment:

Drug: Expanded adipose-derived stem cells