Allogene MSCs TransplantationNCT01256125
Allogene MSCs Transplantation in Patients With Chronic Liver Diseases Through Peripheral Vein.
An observational study of Allogene MSCs Transplantation and Chronic Liver Diseases Patients, run by Sun Yat-sen University at 1 site in China.
Trial summary
Allogene MSCs transplantation will be performed in patients with chronic liver diseases through peripheral vein and therapeutic effects including short-term effects and long-term follow-up will be compared and investigated. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Allogene MSCs Transplantation, Chronic Liver Diseases Patients, Peripheral Vein
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to not given
- Phase
- Observational
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease and so on.
Who may be able to join
- chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease.
- age: 15-65 years old.
Who cannot join
- pregnant women and women in lactation.
- other systems and organs disfunction
- space-occupying lesion were found in liver.
- concurrent infection with HIV and other immunodeficiency diseases.
- DIC and active bleeding were confirmed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Liang Peng, Dr., +86-013533978874, pzp33@hotmail.com
Jing Liu, Master, +86-013556051920, diudiu1203@163.com
About this study
Official title: Therapeutic Effects of Allogene MSCs Transplantation in Patients With Chronic Liver Diseases Through Peripheral Vein.
Allogene MSCs transplantation will be performed in patients with chronic liver diseases through peripheral vein and therapeutic effects including short-term effects and long-term follow-up will be compared and investigated.
- Keywords
- allogene MSCs, transplantation, chronic liver diseases, peripheral vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Allogene MSCs transplantation | Allogene MSCs transplantation were performed in patients with chronic liver diseases through peripheral vein plus the same medical treatments. | |
| control | only medical treatments were performed in patients with chronic liver diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term therapeutic effects at 1-8 weeks after Allogene MSCs transplantation through peripheral vein.
Measured: 1-8 weeks after transplantation
Secondary outcomes (1)
Long-term follow-up of Allogene MSCs transplantation through peripheral vein.
Measured: 3-60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogene MSCs TransplantationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256125
- Sponsor's protocol ID
- SunYat-sen U 11-5-1
- Status last verified
- Oct 2010
- First submitted
- 7 Dec 2010
- Last updated
- 8 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Allogene MSCs Transplantation in Patients With Chronic Liver Diseases Through Peripheral Vein.
- ClinicalTrials.gov ID
- NCT01256125
- Acronym / sponsor ID
- SunYat-sen U 11-5-1
- Keywords
- allogene MSCs, transplantation, chronic liver diseases, peripheral vein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2010
- First posted
- 8 Dec 2010 (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.
Allogene MSCs transplantation will be performed in patients with chronic liver diseases through peripheral vein and therapeutic effects including short-term effects and long-term follow-up will be compared and investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogene MSCs transplantation | – | –Allogene MSCs transplantation were performed in patients with chronic liver diseases through peripheral vein plus the same medical treatments. |
| control | – | –only medical treatments were performed in patients with chronic liver diseases. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease and so on.
Key inclusion criteria (2 listed)
- chronic liver diseases including: viral hepatitis, alcoholic liver disease, autoimmune liver disease.
- age: 15-65 years old.
Key exclusion criteria (5 listed)
- pregnant women and women in lactation.
- other systems and organs disfunction
- space-occupying lesion were found in liver.
- concurrent infection with HIV and other immunodeficiency diseases.
- DIC and active bleeding were confirmed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short-term therapeutic effects at 1-8 weeks after Allogene MSCs transplantation through peripheral vein.
Time frame: 1-8 weeks after transplantation
1 secondary outcome
Long-term follow-up of Allogene MSCs transplantation through peripheral vein.
Time frame: 3-60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2010.
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.
Department of Infectious Diseases, 3rd Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogene MSCs Transplantation and Chronic Liver Diseases Patients, run by Sun Yat-sen University 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 2 inclusion and 5 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 8 Dec 2010. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term therapeutic effects at 1-8 weeks after Allogene MSCs transplantation through peripheral vein. (time frame: 1-8 weeks after transplantation). 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 8 Dec 2010.