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

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

Status and phase: Completed; Phase 2; Phase 1

Conditions: Corneal Disease; Corneal Ulcer; Corneal Dystrophy

Treatments: Biological: limbal stem cells; Other: standard treatment; Biological: mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04484402

IBCE_LSC

Details and patient eligibility

About

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

Full 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%

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

mesenchymal stem cells

Experimental group

Description:

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

Treatment:

Other: standard treatment

Biological: mesenchymal stem cells

limbal stem cells

Experimental group

Description:

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

Treatment:

Biological: limbal stem cells

Other: standard treatment

control

Active Comparator group

Description:

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

Treatment:

Other: standard treatment