Ocular Corneal BurnPhase 1/2NCT03237442
Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
A Phase 1/2 study testing human umbilical cord mesenchymal stem cells in people with Ocular Corneal Burn, run by Guangzhou Saliai Stem Cell Science and Technology Co. Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ocular Corneal Burn
- What is being tested?
- human umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- associated with corneal ulcer or endoophthalmitis;
- uncontrolled hypertension(>=150/95 mmHg);
- abnormal liver and renal function;
- the pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
Yanyan Ma
About this study
Official title: Placebo-Controlled,Randomized,Double-blind Trial of Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
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.
- Conditions
- Ocular Corneal Burn
- Being tested
- human umbilical cord mesenchymal stem cells, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human umbilical cord mesenchymal stem cellsBiological
human UC-MSCs: 0.2ml(about 2*10^6 cells) subconjunctival injection
placeboBiological
Saline injection
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Not described Receives: Biological: human umbilical cord mesenchymal stem cells |
| group 2 | Active comparator | Not described Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percent of cornea perforation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Jan 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Corneal BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237442
- Sponsor's protocol ID
- SSCST-MSC-OCB-01
- Status last verified
- Jul 2017
- First submitted
- 30 Jul 2017
- Last updated
- 2 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled,Randomized,Double-blind Trial of Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn
- ClinicalTrials.gov ID
- NCT03237442
- Acronym / sponsor ID
- SSCST-MSC-OCB-01
- Conditions
- Ocular Corneal Burn
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Biological: human umbilical cord mesenchymal stem cells |
| group 2 | Active comparator | Biological: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human umbilical cord mesenchymal stem cellshuman UC-MSCs: 0.2ml(about 2*10^6 cells) subconjunctival injection | Biological | group 1 |
| placeboSaline injection | Biological | group 2 |
Primary outcome
the percent of cornea perforation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing human umbilical cord mesenchymal stem cells in people with Ocular Corneal Burn, run by Guangzhou Saliai Stem Cell Science and Technology Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wanling Chen (0086-20-37792600, chenwanling@saliai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percent of cornea perforation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.