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Trial record 11 of 32 for:    Recruiting, Not yet recruiting, Available Studies | "Facial Injuries"

Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn

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ClinicalTrials.gov Identifier: NCT03237442
Recruitment Status : Not yet recruiting
First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ocular Corneal Burn Biological: human umbilical cord mesenchymal stem cells Biological: placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled,Randomized,Double-blind Trial of Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: group 1 Biological: human umbilical cord mesenchymal stem cells
human UC-MSCs: 0.2ml(about 2*10^6 cells) subconjunctival injection

Active Comparator: group 2 Biological: placebo
Saline injection




Primary Outcome Measures :
  1. the percent of cornea perforation [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237442


Contacts
Contact: Wanling Chen 0086-20-37792600 chenwanling@saliai.com

Locations
China, Guangdong
The First Affiliated Hospital of Jinan University Recruiting
Guangzhou, Guangdong, China
Contact: Yanyan Ma         
Sponsors and Collaborators
Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.

Responsible Party: Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.
ClinicalTrials.gov Identifier: NCT03237442     History of Changes
Other Study ID Numbers: SSCST-MSC-OCB-01
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Burns
Eye Burns
Wounds and Injuries
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases