Immune Function in BloodPhase 3NCT01854125

Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

A Phase 3 study testing autologous bone marrow mesenchymal stem cells transplantation and autologous bone marrow msenchymal stem cells transplantation in people with Immune Function in Blood and Liver Function in Blood, run by Nanjing PLA General Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Immune Function in Blood, Liver Function in Blood, Variation of Ascites
What is being tested?: autologous bone marrow mesenchymal stem cells transplantation and autologous bone marrow msenchymal stem cells transplantation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: May 2013to Jan 2014
Phase: Phase 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18~65 years. Ultrasonographic evidences of cirrhosis. hepatic cirrhosis patients with refractory ascite.

Who cannot join

history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
Prothrombin time is less than 30s. Severe problems in other vital organs(e.g.the heart,renal or lungs). Liver tumor on ultrasonography, CT or MRI examination. Pregnant or lactating women. Imaging evidences of vascular thromboses.
-
-

Trial locations and contacts

1 site in 1 country.

China1 site

Jinling Hospital
Nanjing, Jiangsu, 210002

Other trials in China

About this study

Official title: Efficacy of Autologous Mesenchymal Stem Cell Transplantation Via Liver Artery in Liver Cirrhosis Patients With Refractory Ascites

Liver cirrhosis (LC) is the final destiny in chronic liver disease.The quality of life in liver cirrhosis patients with refractory ascites are very wretched. The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via liver artery in Child-Pugh B and C stage of liver cirrhosis patients with refractory ascites. The immunomodulatory impact of MSCs in fibrosis was confirmed, and several clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research the investigators will study the affect and influence of MSCs in the patients,include assay of liver function,variation of ascites,Child-Pugh score etc.

Conditions: Immune Function in Blood, Liver Function in Blood, Variation of Ascites, Characters of Quality of Life, Child-Pugh Score
Being tested: autologous bone marrow mesenchymal stem cells transplantation, autologous bone marrow msenchymal stem cells transplantation
Keywords: immun function, liver function, ascites, quality of life, Child-Pugh score
Medical subject headings: Ascites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

autologous bone marrow mesenchymal stem cells transplantationBiological
Autologous MSCs were infused to patients using interventional method via hepatic artery . The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes.
autologous bone marrow msenchymal stem cells transplantationBiological

Study groups in NCT01854125
Study group	Role	What they receive
autologous bone marrow mesenchymal stem cells transplantation	Active comparator	Every patient is given 1x106 MSCs per kg infused via liver artery Receives: Biological: autologous bone marrow mesenchymal stem cells transplantation; Biological: autologous bone marrow msenchymal stem cells transplantation
mesenchymal stem cells transplantation	Active comparator	autologous bone marrow mesenchymal stem cells transplantation Receives: Biological: autologous bone marrow mesenchymal stem cells transplantation; Biological: autologous bone marrow msenchymal stem cells transplantation
stem cells transplantation	Experimental	autologous bone marrow mesenchymal stem cells transplantation Receives: Biological: autologous bone marrow mesenchymal stem cells transplantation; Biological: autologous bone marrow msenchymal stem cells transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

change in immune function,liver function in blood
Measured: before and one to 12 weeks after therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Jan 2014

First posted15 May 2013 (estimated)
Study startMay 2013
Primary completionJan 2014 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Immune Function in BloodStudies 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01854125
Sponsor's protocol ID: NanjingPLAGH1
Other IDs: Jinling 01
Status last verified: May 2013
First submitted: 12 May 2013
Last updated: 15 May 2013
Results posted: No
Data monitoring committee: Yes

Publications

Kharaziha P, Hellstrom PM, Noorinayer B, Farzaneh F, Aghajani K, Jafari F, Telkabadi M, Atashi A, Honardoost M, Zali MR, Soleimani M. Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I-II clinical trial. Eur J Gastroenterol Hepatol. 2009 Oct;21(10):1199-205. doi: 10.1097/MEG.0b013e32832a1f6c.
PubMed 19455046

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
Type 2 Diabetes
RecruitingObservational study
Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer
Non-GI Cancers, Cancer of Gastrointestinal Tract
RecruitingObservational study
Cytapheresis of Volunteer Donors
Healthy Volunteers
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia

All Immune Function in Blood trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Autologous Mesenchymal Stem Cell Transplantation Via Liver Artery in Liver Cirrhosis Patients With Refractory Ascites
ClinicalTrials.gov ID: NCT01854125
Acronym / sponsor ID: NanjingPLAGH1
Conditions: Immune Function in Blood, Liver Function in Blood, Variation of Ascites, Characters of Quality of Life, Child-Pugh Score
Keywords: immun function, liver function, ascites, quality of life, Child-Pugh score
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Nanjing PLA General HospitalUniversity, hospital or other
Study start: May 2013
Primary completion: Jan 2014 (estimated)
First posted: 15 May 2013 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
autologous bone marrow mesenchymal stem cells transplantation	Active comparator	Biological: autologous bone marrow mesenchymal stem cells transplantation, Biological: autologous bone marrow msenchymal stem cells transplantationEvery patient is given 1x106 MSCs per kg infused via liver artery
mesenchymal stem cells transplantation	Active comparator	Biological: autologous bone marrow mesenchymal stem cells transplantation, Biological: autologous bone marrow msenchymal stem cells transplantationautologous bone marrow mesenchymal stem cells transplantation
stem cells transplantation	Experimental	Biological: autologous bone marrow mesenchymal stem cells transplantation, Biological: autologous bone marrow msenchymal stem cells transplantationautologous bone marrow mesenchymal stem cells transplantation

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Aged 18~65 years. Ultrasonographic evidences of cirrhosis. hepatic cirrhosis patients with refractory ascite.

Key exclusion criteria (4 listed)

history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
Prothrombin time is less than 30s. Severe problems in other vital organs(e.g.the heart,renal or lungs). Liver tumor on ultrasonography, CT or MRI examination. Pregnant or lactating women. Imaging evidences of vascular thromboses.
-
-

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
autologous bone marrow mesenchymal stem cells transplantationAutologous MSCs were infused to patients using interventional method via hepatic artery . The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes.	Biological	autologous bone marrow mesenchymal stem cells transplantation, mesenchymal stem cells transplantation, stem cells transplantation
autologous bone marrow msenchymal stem cells transplantation	Biological	autologous bone marrow mesenchymal stem cells transplantation, mesenchymal stem cells transplantation, stem cells transplantation

Primary outcome

change in immune function,liver function in blood
Time frame: before and one to 12 weeks after therapy

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
Background: PubMed 19455046Kharaziha P, Hellstrom PM, Noorinayer B, Farzaneh F, Aghajani K, Jafari F, Telkabadi M, Atashi A, Honardoost M, Zali MR, Soleimani M. Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I-II clinical trial. Eur J Gastroenterol Hepatol. 2009 Oct;21(10):1199-205. doi: 10.1097/MEG.0b013e32832a1f6c.

Related trials for Immune Function in Blood

Recruiting
6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
Type 2 Diabetes
RecruitingObservational study
Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer
Non-GI Cancers, Cancer of Gastrointestinal Tract
RecruitingObservational study
Cytapheresis of Volunteer Donors
Healthy Volunteers
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia

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.

Fangyu Wang, MD/PhD study director

Nanjing University

Fangyu Wang, MD/PhD study director

Nanjin University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 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 15 May 2013. 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 phase mean?

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?

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?

change in immune function,liver function in blood (time frame: before and one to 12 weeks after therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01854125, which also lists 1 linked publication.

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 15 May 2013.