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NCT04484402 Clinical Trial

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

Corneal Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04484402
Other study ID # IBCE_LSC
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 3, 2016
Est. completion date December 30, 2019

Study information
Verified date July 2020
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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%

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution
• limbal stem cells
Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution
Other:
• standard treatment
Standard treatment according to the Clinical protocols

Locations
Country Name City State
Belarus Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Minsk

Sponsors (2)
Lead Sponsor Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

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