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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04484402

Enrollment

Registered

2020-07-23

Start date

2016-10-03

Completion date

2019-12-30

Last updated

2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Disease, Corneal Dystrophy, Corneal Ulcer

Keywords

Corneal Disease

Brief summary

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

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%

Interventions

OTHERstandard treatment

Standard treatment according to the Clinical protocols

BIOLOGICALmesenchymal stem cells

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

BIOLOGICALlimbal stem cells

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of cured patients	2 month	Number of patients cured
Number of patients with treatment-related adverse events	4 weeks	MSC/LSC application related adverse events assessed by blood count, liver and function tests

Countries

Belarus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026