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Autologous Adipose-Derived Adult Stem Cell Implantation for Corneal Diseases (ADASCs-CT-CD)

NCT05279157 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-05-06

No results posted yet for this study

Summary

Cellular therapy of the corneal stroma with implantation of mesenchymal stem cells derived from autologous adipose tissue with or without a carrier (scaffold) composed by decellularized human donor corneal stroma is used in patients with corneal diseases such as corneal dystrophies, and keratoconus.

For this purpose, the study planned to assess the enhancement of visual acuity, pachymetric, and aberrometric parameters with implantation of autologous mesenchymal adipose tissue-derived adult stem cells (ADASCs) alone, 120 µm thickness of decellularized or recellularized laminas with ADASCs. Three groups will be included in the study: (1) Implantation of a single dose of ADASCs alone without scaffold. (2) Implantation of decellularized human corneal lamina without ADASCs. (3) Implantation of the recellularized human corneal lamina with ADASCs.

Conditions

  • Ophthalmological Disorder
  • Corneal Dystrophy
  • Treatment
  • Therapy
  • Keratoconus

Interventions

PROCEDURE

Implantation

Procedure: Implantation The ophthalmologist will carry out the implantation of the ADASCs cells with or without scaffold in the intrastromal cornea of the patient

PROCEDURE

Lipoaspiration

Procedure: Lipoaspiration The patient will have a liposuction surgery from which the autologous ADASCs implant in the cornea will be obtained. Procedure: Implantation The ophthalmologist will carry out the implantation of the ADASCs with or without scaffold in the intrastromal cornea of the patient

Sponsors & Collaborators

  • Universidad Miguel Hernandez de Elche

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Vissum, Instituto Oftalmológico de Alicante

    lead OTHER

Principal Investigators

  • Jorge L Alio, MD, PhD · Universidad Miguel Hernandez, Elche, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-02-05
Completion
2023-02-05

Countries

  • Spain

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 NCT05279157 on ClinicalTrials.gov