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

NCT ID: NCT04484402

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-03

Study Completion Date

2019-12-30

Brief Summary

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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

Detailed Description

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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%

Conditions

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Corneal Ulcer Corneal Disease Corneal Dystrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mesenchymal stem cells

Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells

Group Type EXPERIMENTAL

mesenchymal stem cells

Intervention Type BIOLOGICAL

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

standard treatment

Intervention Type OTHER

Standard treatment according to the Clinical protocols

limbal stem cells

Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells

Group Type EXPERIMENTAL

limbal stem cells

Intervention Type BIOLOGICAL

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

standard treatment

Intervention Type OTHER

Standard treatment according to the Clinical protocols

control

Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type OTHER

Standard treatment according to the Clinical protocols

Interventions

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mesenchymal stem cells

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

Intervention Type BIOLOGICAL

limbal stem cells

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

Intervention Type BIOLOGICAL

standard treatment

Standard treatment according to the Clinical protocols

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian State Medical University

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Igor Volotovski, Prof

Role: STUDY_DIRECTOR

Head of the Lab of Institute of Biophysics and Cell Engineering

Liudmila Marchenko, Prof

Role: STUDY_DIRECTOR

Head of the Department of eyes diseases of Belarusian State Medical University

Zinaida Kvacheva

Role: PRINCIPAL_INVESTIGATOR

Leading researcher, Institute of Biophysics and Cell Engineering

Locations

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

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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IBCE_LSC

Identifier Type: -

Identifier Source: org_study_id

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