Primary Sclerosing CholangitisPhase 1/2NCT03516006
Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
A Phase 1/2 study testing UCMSC and UDCA in people with Primary Sclerosing Cholangitis, run by Fuzhou General Hospital.
Trial summary
Primary sclerosing cholangitis (PSC) is an idiopathic condition with intrahepatic cholangitis and fibrosis, leading to multifocal bile duct stricture. Its main clinical manifestations are chronic cholestatic lesions and is deemed as autoimmune liver disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- UCMSC and UDCA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- progressive PSC
- willing to give consent
Who cannot join
- decompensated liver cirrhosis
- total serum bilirubin >5ULN
- refractory ascites
- serum creatinine >1.5mg/dL
- Cirrhotic nodules with malignant tendencies
- primary biliary cholangitis
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- IgG4-associated sclerosing cholangitis
- non-PSC induced bile duct stones
- biliary tract trauma
- recurrent suppurative cholangitis
- neoplastic disease
- pancreatic disease
About this study
Official title: Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is an idiopathic condition with intrahepatic cholangitis and fibrosis, leading to multifocal bile duct stricture. Its main clinical manifestations are chronic cholestatic lesions and is deemed as autoimmune liver disease. PSC are immune abnormalities that occurs in patients with genetic susceptibility. No other pathogenesis is revealed yet. Ursodeoxycholic acid is used as an empirical treatment, and there is no approved drug or a acceptable treatment regimen. The disease often progresses to liver decompensation and requires liver transplantation. In recent years, the clinical application of stem cell therapy has seen many important advances. Stem cells are characterized with properties of multiple differentiation, repair of damaged tissue and immuno-modulation. This study aims to employ UCMSCs to treat PSC patients and observe its efficacy and safety, and to explore the possible therapeutic mechanisms.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- UCMSC, UDCA
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCMSCDrug
infusion of aUCMSC at day 0, 7, 14, and 21
UDCADrug
oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d
| Study group | Role | What they receive |
|---|---|---|
| UCMSC | Experimental | infusion of aUCMSC and Ursodeoxycholic acid therapy Receives: Drug: UCMSC; Drug: UDCA |
| UDCA | Active comparator | Ursodeoxycholic acid therapy 15mg/kg/d Receives: Drug: UDCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse effects regarding UCMSC infusion
Measured: 1 year
Secondary outcomes (3)
Pathological score of liver inflammation
Measured: 1 year
Changes of biliary lesions in magnetic resonance image
softening in stiffness of bile duct
Measured: 1 year
alanine aminotransferase
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongliang Li, Fuzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516006
- Sponsor's protocol ID
- UCMSC-PSC
- Status last verified
- Apr 2018
- First submitted
- 20 Sep 2017
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
- ClinicalTrials.gov ID
- NCT03516006
- Acronym / sponsor ID
- UCMSC-PSC
- Conditions
- Primary Sclerosing Cholangitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 4 May 2018 (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.
Primary sclerosing cholangitis (PSC) is an idiopathic condition with intrahepatic cholangitis and fibrosis, leading to multifocal bile duct stricture. Its main clinical manifestations are chronic cholestatic lesions and is deemed as autoimmune liver disease. PSC are immune abnormalities that occurs in patients with genetic susceptibility. No other pathogenesis is revealed yet. Ursodeoxycholic acid is used as an empirical treatment, and there is no approved drug or a acceptable treatment regimen. The disease often progresses to liver decompensation and requires liver transplantation. In recent years, the clinical application of stem cell therapy has seen many important advances. Stem cells are characterized with properties of multiple differentiation, repair of damaged tissue and immuno-modulation. This study aims to employ UCMSCs to treat PSC patients and observe its efficacy and safety, and to explore the possible therapeutic mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCMSC | Experimental | Drug: UCMSC, Drug: UDCAinfusion of aUCMSC and Ursodeoxycholic acid therapy |
| UDCA | Active comparator | Drug: UDCAUrsodeoxycholic acid therapy 15mg/kg/d |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- progressive PSC
- willing to give consent
Key exclusion criteria (12 listed)
- decompensated liver cirrhosis
- total serum bilirubin >5ULN
- refractory ascites
- serum creatinine >1.5mg/dL
- Cirrhotic nodules with malignant tendencies
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 |
|---|---|---|
| UCMSCinfusion of aUCMSC at day 0, 7, 14, and 21 | Drug | UCMSC |
| UDCAoral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d | Drug | UCMSC, UDCA |
Primary outcome
adverse effects regarding UCMSC infusion
Time frame: 1 year
3 secondary outcomes
Pathological score of liver inflammation
Time frame: 1 year
Changes of biliary lesions in magnetic resonance image
Time frame: 1 year
alanine aminotransferase
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UCMSC and UDCA in people with Primary Sclerosing Cholangitis, run by Fuzhou General Hospital.
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 2 inclusion and 12 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 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse effects regarding UCMSC infusion (time frame: 1 year). 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 4 May 2018.