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

July 28, 2020 updated by: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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%

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220072
        • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • inflammatory-dystrophic diseases of the cornea:

    1. Epithelial defects of the cornea, ulcerative keratitis of various etiology, resistant to standard methods of treatment
    2. Dystrophic diseases of the cornea, accompanied by edema
    3. Burns of the cornea
    4. Neurotrophic forms of keratitis
    5. Persistent post-traumatic, postoperative, contusion keratitis and keratopathy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: mesenchymal stem cells
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells
Biological: mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution
Other: standard treatment
Standard treatment according to the Clinical protocols
EXPERIMENTAL: limbal stem cells
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells
Other: standard treatment
Standard treatment according to the Clinical protocols
Biological: limbal stem cells
Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution
ACTIVE_COMPARATOR: control
Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment
Other: standard treatment
Standard treatment according to the Clinical protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cured patients
Time Frame: 2 month
Number of patients cured
2 month
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Belarusian State Medical University

Investigators

  • Study Director: Liudmila Marchenko, Prof, Head of the Department of eyes diseases of Belarusian State Medical University
  • Principal Investigator: Zinaida Kvacheva, Leading researcher, Institute of Biophysics and Cell Engineering

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 3, 2016

Primary Completion (ACTUAL)

December 30, 2019

Study Completion (ACTUAL)

December 30, 2019

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (ACTUAL)

July 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCE_LSC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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