Ischemic-type Biliary LesionsPhase 2/3NCT02223897
Mesenchymal Stem Cells Transplantation for Ischemic-type Biliary Lesions
A Phase 2/3 study testing huc-MSCs in people with Ischemic-type Biliary Lesions, run by Yang Yang at 1 site in China.
Trial summary
Ischemic-type biliary lesions (ITBLs) are a major cause of graft loss and mortality after orthotopic liver transplantation (OLT). For now, there are still lacking effective treatment for ITBLs. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ischemic-type Biliary Lesions
- What is being tested?
- huc-MSCs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jun 2018
- Phase
- Phase 2/3
- 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
- benign end-stage liver disease patients with liver transplantation.
- ages of 18 and 60 years.
- first liver transplant.
- gamma-glutamyltransferase > 300 U/L for 2 weeks, and there was no or low enhancement of the wall of the hilar bile duct in arterial phase via contrast-enhanced ultrasonography.
- Written informed consent.
Who cannot join
- second or combined organ transplant recipient.
- vital organs failure (Cardiac, Renal or Respiratory, et al).
- clinically active bacterial, fungal, viral or parasitic infection.
- other candidates who are judged to be not applicable to this study by investigators.
Trial locations and contacts
1 site in 1 country.
Yang yang, MD contact
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Yang Yang, PHD, yysysu@163.com
Yingcai Zhang, 76207884@qq.com
About this study
Official title: Umbilical Cord Mesenchymal Stem Cells Transplantation for Treatment of Patients With Ischemic-type Biliary Lesions After Liver Transplantation
Ischemic-type biliary lesions (ITBLs) are a major cause of graft loss and mortality after orthotopic liver transplantation (OLT). For now, there are still lacking effective treatment for ITBLs. The purpose of this study is to confirm whether human umbilical cord mesenchymal stem cells are effective in the treatment,or prevention of Ischemic-type Biliary Lesions after liver transplantation.
Read the detailed description
Advances in organ preservation techniques, immunosuppressive regimens, and surgical techniques have resulted in reduced rates of infection, acute rejection and vascular complications after orthotopic liver transplantation (OLT). However, ischemic-type biliary lesions (ITBLs) are still one of the most serious complications after OLT, with a usual reported incidence of 5-15%, and an incidence of up to 26% in some studies. 46% patients with ITBLs require re-transplantation after 2 years of OLT.
Mesenchymal stem cells (MSCs),a kind of pluripotent stem cells,can differentiate into vascular endothelial cells, which participate in angiogenesis in ischemic tissue. MSCs can also stimulate the proliferation and migration of mature endothelial cells via paracrine.Furthermore, MSCs secret a variety of cytokines and growth factors, such as vascular endothelial growth factor, human basic fibroblast growth factor, hepatocyte growth factor, interleukin-1 and interleukin-8, etc., which also induce angiogenesis.
Participants in the study will be randomly assigned to one of two treatment arms:
- Arm A: Participants will receive 6 months of standard regular treatment for ITBLs plus huc-MSCs treatment.
- Arm B: Participants will receive 6 months of standard regular treatment for ITBLs plus placebo. huc-MSCs will be prepared according to standard procedures and is collected in plastic bags containing anti coagulant. MSCs are given via i.v. After huc-MSCs transfusion, patients are followed up once per week(in the first months,<1M),once per 2 week(1-3M)and once per month(3-6M), and the evaluation of liver function and biliary blood supply was performed.
- Conditions
- Ischemic-type Biliary Lesions
- Being tested
- huc-MSCs, Placebo
- Keywords
- Liver transplantation, Biliary complication, mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
huc-MSCsDrug
Also called Umbilical Cord-Derived Mesenchymal Stem Cells
Received conventional treatment and huc-MSCs once per week for the first month and once per month for 6 months(9 times in total), at a dose of 1×106 huc-MSCs/kg body weight.
PlaceboDrug
Also called saline solution
Received conventional treatment and 50 ml saline solution once per week for the first month and once per month for 6 months(9 times in total).
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment, huc-MSCs | Experimental | Received conventional treatment and huc-MSCs once per week for the first month and once per month for 6 months(9 times in total), at a dose of 1×106 huc-MSCs/kg body weight. Receives: Drug: huc-MSCs |
| Conventional plus placebo | Placebo comparator | Received conventional treatment and 50 ml saline once per week for the first month and once per month for 6 months(9 times in total). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of ITBLs
Measured: 18 months
Secondary outcomes (2)
Changes in biliary enzymology
Measured: 18 months
Biliary blood supply
Biliary blood supply indicated by contrast-enhanced ultrasound.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic-type Biliary LesionsStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Yang, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yang Yang, MD, Study chair, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223897
- Sponsor's protocol ID
- 2014006
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Mesenchymal Stem Cells Transplantation for Treatment of Patients With Ischemic-type Biliary Lesions After Liver Transplantation
- ClinicalTrials.gov ID
- NCT02223897
- Acronym / sponsor ID
- 2014006
- Conditions
- Ischemic-type Biliary Lesions
- Keywords
- Liver transplantation, Biliary complication, mesenchymal stem cells
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Yang YangUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 22 Aug 2014 (estimated)
- 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.
Ischemic-type biliary lesions (ITBLs) are a major cause of graft loss and mortality after orthotopic liver transplantation (OLT). For now, there are still lacking effective treatment for ITBLs. The purpose of this study is to confirm whether human umbilical cord mesenchymal stem cells are effective in the treatment,or prevention of Ischemic-type Biliary Lesions after liver transplantation.
Detailed description
Advances in organ preservation techniques, immunosuppressive regimens, and surgical techniques have resulted in reduced rates of infection, acute rejection and vascular complications after orthotopic liver transplantation (OLT). However, ischemic-type biliary lesions (ITBLs) are still one of the most serious complications after OLT, with a usual reported incidence of 5-15%, and an incidence of up to 26% in some studies. 46% patients with ITBLs require re-transplantation after 2 years of OLT.
Mesenchymal stem cells (MSCs),a kind of pluripotent stem cells,can differentiate into vascular endothelial cells, which participate in angiogenesis in ischemic tissue. MSCs can also stimulate the proliferation and migration of mature endothelial cells via paracrine.Furthermore, MSCs secret a variety of cytokines and growth factors, such as vascular endothelial growth factor, human basic fibroblast growth factor, hepatocyte growth factor, interleukin-1 and interleukin-8, etc., which also induce angiogenesis.
Participants in the study will be randomly assigned to one of two treatment arms:
- Arm A: Participants will receive 6 months of standard regular treatment for ITBLs plus huc-MSCs treatment.
- Arm B: Participants will receive 6 months of standard regular treatment for ITBLs plus placebo. huc-MSCs will be prepared according to standard procedures and is collected in plastic bags containing anti coagulant. MSCs are given via i.v. After huc-MSCs transfusion, patients are followed up once per week(in the first months,<1M),once per 2 week(1-3M)and once per month(3-6M), and the evaluation of liver function and biliary blood supply was performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment, huc-MSCs | Experimental | Drug: huc-MSCsReceived conventional treatment and huc-MSCs once per week for the first month and once per month for 6 months(9 times in total), at a dose of 1×106 huc-MSCs/kg body weight. |
| Conventional plus placebo | Placebo comparator | Drug: PlaceboReceived conventional treatment and 50 ml saline once per week for the first month and once per month for 6 months(9 times in total). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- benign end-stage liver disease patients with liver transplantation.
- ages of 18 and 60 years.
- first liver transplant.
- gamma-glutamyltransferase > 300 U/L for 2 weeks, and there was no or low enhancement of the wall of the hilar bile duct in arterial phase via contrast-enhanced ultrasonography.
- Written informed consent.
Key exclusion criteria (4 listed)
- second or combined organ transplant recipient.
- vital organs failure (Cardiac, Renal or Respiratory, et al).
- clinically active bacterial, fungal, viral or parasitic infection.
- other candidates who are judged to be not applicable to this study by investigators.
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 |
|---|---|---|
| huc-MSCsAlso: Umbilical Cord-Derived Mesenchymal Stem CellsReceived conventional treatment and huc-MSCs once per week for the first month and once per month for 6 months(9 times in total), at a dose of 1×106 huc-MSCs/kg body weight. | Drug | Conventional treatment, huc-MSCs |
| PlaceboAlso: saline solutionReceived conventional treatment and 50 ml saline solution once per week for the first month and once per month for 6 months(9 times in total). | Drug | Conventional plus placebo |
Primary outcome
The incidence of ITBLs
Time frame: 18 months
2 secondary outcomes
Changes in biliary enzymology
Time frame: 18 months
Biliary blood supply
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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.
Yang yang, MD contact
Yang Yang, MD study chair
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing huc-MSCs in people with Ischemic-type Biliary Lesions, run by Yang Yang 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 5 inclusion and 4 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 22 Aug 2014. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yang yang, MD (yysysu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of ITBLs (time frame: 18 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 22 Aug 2014.