Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn

Guangzhou Saliai Stem Cell Science and Technology

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Ocular Corneal Burn

Treatments: Biological: human umbilical cord mesenchymal stem cells; Biological: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03237442

SSCST-MSC-OCB-01

Details and patient eligibility

About

Ocular chemical burn is one of the causes of vision loss in China, and there are no satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal burn in human.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must be ocular burns including chemically burned or the thermally burned;
• the subjects are willing to accept this research, and promise to coordinate with the researchers during the follow up period;
• the subjects should abide by the laws and rules of the study.

Exclusion criteria

• the visual acuity is blind in any of the eye;
• have corneal perforation or have the corneal perforation tendency;
• have been accepted surgery on eyeball after trauma;
• IOP>=25 mmHg even after antiglaucoma;
• have the history of other corneal disease or surgery;
• have the history of radiotherapy or surgery in the eyeball;
• associated with corneal ulcer or endoophthalmitis;
• uncontrolled hypertension(>=150/95 mmHg);
• abnormal liver and renal function;
• the pregnant women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups

group 1

Experimental group

Treatment:

Biological: human umbilical cord mesenchymal stem cells

group 2

Active Comparator group

Treatment:

Biological: placebo