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NCT Number: NCT04484402

Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Stem Cells

Treatment of patients with inflammatory-dystrophic diseases of the cornea using autologous limbal stem cells (corneal epithelial stem cells) or adipose-derived mesenchymal stem cells

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Key information

Conditions

Corneal Ulcer Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Disease Corneal Diseases Corneal Dystrophies, Hereditary Corneal Dystrophy Eye Diseases Eye Diseases, Hereditary Eye Infections Genetic Diseases, Inborn Infections Keratitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, 220072, Belarus

About this study

In order to treat inflammatory and dystrophic diseases of the cornea perilimbal injections of cultured autologous stem cells are performed. Corneal (limbal) epithelial stem cells (LSC) or mesenchymal stem cells derived from adipose tissue (ADSC) are mixed with sodium hyaluronate 1%

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • inflammatory-dystrophic diseases of the cornea:
  • Epithelial defects of the cornea, ulcerative keratitis of various etiology, resistant to standard methods of treatment
  • Dystrophic diseases of the cornea, accompanied by edema
  • Burns of the cornea
  • Neurotrophic forms of keratitis
  • Persistent post-traumatic, postoperative, contusion keratitis and keratopathy

Exclusion criteria

  • Pregnancy.
  • Viral hepatitis B and C, HIV, tubeculosis and other chronic viral and bacterial infections.
  • Cancer or leukemia
  • Any diseases in the stage of decompensation.
  • Mental disorders.
  • Anomalies of eye refraction

Treatment and study plan

Mesenchymal stem cells

Biological

Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution

limbal stem cells

Biological

Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution

standard treatment

Other

Standard treatment according to the Clinical protocols

Primary outcomes

  1. Number of cured patients

    Time frame: 2 month

    Number of patients cured

  2. Number of patients with treatment-related adverse events

    Time frame: 4 weeks

    MSC/LSC application related adverse events assessed by blood count, liver and function tests

Sponsors and collaborators

Lead sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Other Gov

Collaborators

  • Belarusian State Medical University

Registry information

Official study title

Treatment of Patients With Inflammatory-dystrophic Diseases of the Cornea Using Autologous Limbal Stem Cells (Corneal Epithelial Stem Cells) or Adipose-derived Mesenchymal Stem Cells

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2020
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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