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

Phase 1

Completed

• Conditions: Corneal Dystrophy; Corneal Disease; Corneal Ulcer
• Interventions: Biological: limbal stem cells; Biological: mesenchymal stem cells; Other: standard treatment

• Registration Number: NCT04484402
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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%

Study Timeline

• Study Start: 2016-10-03
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-23
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
limbal stem cells	limbal stem cells	Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells
mesenchymal stem cells	standard treatment	Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells
limbal stem cells	standard treatment	Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived limbal stem cells
control	standard treatment	Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment
mesenchymal stem cells	mesenchymal stem cells	Patients with inflammatory-dystrophic diseases of the cornea receiving standard treatment plus adipose-derived mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus