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Autologous Adipose-Derived Adult Stem Cell Transplantation for Corneal Diseases

NCT02932852 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-10-13

No results posted yet for this study

Summary

Transplantation of cellularized human cornea impregnated and populated by mesenchymal stem cells derived from the patient's adipose tissue. The purpose of the study is to assess the safety, tolerability, and preliminary efficacy of transplantation of a single dose of autologous mesenchymal adipose tissue derived adult stem cells (ADAS) cellularized into laminas for subjects with corneal defects. 3 groups will be included in the study: (1) transplantation of ADAS alone without scaffold, (2) transplantation of scaffold (human corneal decellularized lamina) without ADAS, and (3) transplantation of ADAS cellularized on scaffold (the human corneal decellularized lamina)

Conditions

  • Hereditary Corneal Dystrophy
  • Keratoconus

Interventions

PROCEDURE

Lipoaspiration

The patient will have a liposuction surgery from which the autologous ADAS cell to transplant in the cornea will be obtained.

PROCEDURE

Transplantation

The ophthalmologist will carry out the transplantation of the ADAS cells with or without scaffold in the intrastromal cornea of the patient

Sponsors & Collaborators

  • Reviva Pharmaceuticals

    collaborator INDUSTRY

  • Hospital Universitario La Paz

    collaborator OTHER

  • LASER VISION CENTER IN LIBANON

    collaborator UNKNOWN

  • OPTICA GENERAL IN LIBANON

    collaborator UNKNOWN

  • Vissum, Instituto Oftalmológico de Alicante

    lead OTHER

Principal Investigators

  • Mona El Zarif, OD · Optica General

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-04-30

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02932852 on ClinicalTrials.gov