Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT)

Phase IIa Clinical Trial to Study the Feasability and Security of the Expanded Autologous Stem Cells (ASC) From Lipoaspirate in the Bilateral Limbic Associated Keratopathy Treatment

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01808378

Acronym

HULPOFT

Enrollment

Registered

2013-03-11

Start date

2013-02-28

Completion date

2014-12-31

Last updated

2013-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratopathy

Keywords

Bilateral limbic associated keratopathy, Expanded Adipose Derived Stem Cells

Brief summary

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

Detailed description

Intralesional use by inject of adipose derived stem cells

Interventions

DRUGExpanded adipose-derived stem cells

Local injection of autologousadipose derived stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy	16 weeks	Micro ocular Photography Visual acuity

Secondary

Measure	Time frame	Description
Quality of life assessment using the SF-12 Questionnaire	1, 4, 16, 24 weeks	SF-12 questionnaire
Adverse events	1, 4, 16, 24 weeks	Data collection

Countries

Spain

Contacts

Primary ContactMariano García-Arranz, PhD

mgarciaa.hulp@salud.madrid.org0034 912071022

Backup ContactAna Boto de los Bueis, MD