Liver CirrhosisPhase 1/2NCT02943889
Stem Cell Transplantation in Cirrhotic Patients
A Phase 1/2 study testing Mesenchymal stem cell transplantation in people with Liver Cirrhosis, run by Assiut University.
Trial summary
Chronic liver disease end by liver cirrhosis and increases the risk of cancer development. Chronic liver disease in Egypt is recognized as a serious health problem affecting greater than (20 %) of the population, where the main cause is chronic infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Mesenchymal stem cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Aug 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Decompensated liver cirrhosis child class b or c
Who cannot join
- Patients with portal vein thrombosis, or
- Recent recurrent gastrointestinal bleeding, or
- Hepatocellular carcinoma (HCC), or
- Spontaneous bacterial peritonitis
- Pregnant or lactating women
- Vital organs failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Bone-marrow Derived Stem Cell Transplantation in Patients With Decompensated Liver Cirrhosis: Clinical Trial
Chronic liver disease end by liver cirrhosis and increases the risk of cancer development. Chronic liver disease in Egypt is recognized as a serious health problem affecting greater than (20 %) of the population, where the main cause is chronic infection.
Liver transplantation is still the standard treatment for advanced decompensated liver cirrhosis. However, this treatment is quite limited in clinical practice. Therefore there is a concerted effort around the world to develop regenerative and alternative therapies, so, stem cell-based therapies are emerging as new alternatives to liver transplantation for end-stage liver pathologies.
Read the detailed description
This study aimed to transplant autologous bone marrow derived mesenchymal stem cells to the patients with liver cirrhosis to assess liver tissue regeneration, efficacy and safety of stem cell therapy and finally to establish an alternative treatment modality to liver transplantation.
Medical treatment of liver cirrhosis (the last stage of the illness) is very difficult that leads to high morbidity and mortality rate. Liver transplantation is still the most effective treatment for the patients with liver cirrhosis, However, serious problems are accompanied with liver transplantation, donor shortage, long waiting list, high cost, risk of rejection, operative complications and complications related to immunosuppressive drugs.
"stem cells" are cells in the human body that are capable to renew themselves and differentiate to a diverse range of specialized cell types and can be differentiated to specialized cells in appropriate medias in the laboratory. In recent years, advances in stem cell biology, have made the prospect of tissue regeneration a potential clinical reality, and several studies have shown the great promise that stem cells hold for therapy. mesenchymal stem cell based therapy has shown as promising tool in cirrhotic conditions as this type of cells have the ability to differentiate to different cell types including hepatocytes A series of studies have been performed to assess the application of bone marrow derived mesenchymal stem cells to promote liver regeneration and to alleviate cirrhosis. Some animal-based studies showed that stem cell transplantation could ameliorate liver fibrosis and improve liver functions followed by several clinical trials on human, in patients with advanced liver diseases, these studies demonstrated that stem cell transplantation could significantly reverse hepatic failure with only limited side effects. However, the effectiveness of this therapy in recent clinical trials is still conflicting and need further evaluation.
- Conditions
- Liver Cirrhosis
- Being tested
- Mesenchymal stem cell transplantation
- Keywords
- Mesenchymal stem cells, Liver cirrhosis, Stem cell therapy
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cell transplantationBiological
Bone marrow aspiration by clinical pathologist. Isolation, propagation and differentiation of stem cells will be done in stem cell center. After confirmation of the trans-differentiation into hepatocytes at the laboratory level, it will be infused into the portal vein under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell transplantation | Experimental | This group will include 20 patients with liver cirrhosis, autologous bone marrow derived mesenchymal stem cells will be transplanted to them. Every patient will receive 2 million cells per Kg via portal vein once. Receives: Biological: Mesenchymal stem cell transplantation |
| Control group | No intervention | This group will include 20 patients with liver cirrhosis as control group matching (stem cell group) in age, sex and child score. They will continue on the conventional therapy they already on and no stem cell transplantation will done for them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of liver function in form of improvement in child score
Measured: 6 months
Secondary outcomes (1)
Postpone or to overcome liver transplantation complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Abdeltawab Abdellah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943889
- Sponsor's protocol ID
- SCT-LC
- Status last verified
- Oct 2016
- First submitted
- 27 Sep 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Bone-marrow Derived Stem Cell Transplantation in Patients With Decompensated Liver Cirrhosis: Clinical Trial
- ClinicalTrials.gov ID
- NCT02943889
- Acronym / sponsor ID
- SCT-LC
- Conditions
- Liver Cirrhosis
- Keywords
- Mesenchymal stem cells, Liver cirrhosis, Stem cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 25 Oct 2016 (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.
Chronic liver disease end by liver cirrhosis and increases the risk of cancer development. Chronic liver disease in Egypt is recognized as a serious health problem affecting greater than (20 %) of the population, where the main cause is chronic infection.
Liver transplantation is still the standard treatment for advanced decompensated liver cirrhosis. However, this treatment is quite limited in clinical practice. Therefore there is a concerted effort around the world to develop regenerative and alternative therapies, so, stem cell-based therapies are emerging as new alternatives to liver transplantation for end-stage liver pathologies.
Detailed description
This study aimed to transplant autologous bone marrow derived mesenchymal stem cells to the patients with liver cirrhosis to assess liver tissue regeneration, efficacy and safety of stem cell therapy and finally to establish an alternative treatment modality to liver transplantation.
Medical treatment of liver cirrhosis (the last stage of the illness) is very difficult that leads to high morbidity and mortality rate. Liver transplantation is still the most effective treatment for the patients with liver cirrhosis, However, serious problems are accompanied with liver transplantation, donor shortage, long waiting list, high cost, risk of rejection, operative complications and complications related to immunosuppressive drugs.
"stem cells" are cells in the human body that are capable to renew themselves and differentiate to a diverse range of specialized cell types and can be differentiated to specialized cells in appropriate medias in the laboratory. In recent years, advances in stem cell biology, have made the prospect of tissue regeneration a potential clinical reality, and several studies have shown the great promise that stem cells hold for therapy. mesenchymal stem cell based therapy has shown as promising tool in cirrhotic conditions as this type of cells have the ability to differentiate to different cell types including hepatocytes A series of studies have been performed to assess the application of bone marrow derived mesenchymal stem cells to promote liver regeneration and to alleviate cirrhosis. Some animal-based studies showed that stem cell transplantation could ameliorate liver fibrosis and improve liver functions followed by several clinical trials on human, in patients with advanced liver diseases, these studies demonstrated that stem cell transplantation could significantly reverse hepatic failure with only limited side effects. However, the effectiveness of this therapy in recent clinical trials is still conflicting and need further evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell transplantation | Experimental | Biological: Mesenchymal stem cell transplantationThis group will include 20 patients with liver cirrhosis, autologous bone marrow derived mesenchymal stem cells will be transplanted to them. Every patient will receive 2 million cells per Kg via portal vein once. |
| Control group | No intervention | –This group will include 20 patients with liver cirrhosis as control group matching (stem cell group) in age, sex and child score. They will continue on the conventional therapy they already on and no stem cell transplantation will done for them. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Decompensated liver cirrhosis child class b or c
Key exclusion criteria (6 listed)
- Patients with portal vein thrombosis, or
- Recent recurrent gastrointestinal bleeding, or
- Hepatocellular carcinoma (HCC), or
- Spontaneous bacterial peritonitis
- Pregnant or lactating women
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 |
|---|---|---|
| Mesenchymal stem cell transplantationBone marrow aspiration by clinical pathologist. Isolation, propagation and differentiation of stem cells will be done in stem cell center. After confirmation of the trans-differentiation into hepatocytes at the laboratory level, it will be infused into the portal vein under ultrasound guidance. | Biological | Mesenchymal stem cell transplantation |
Primary outcome
Improvement of liver function in form of improvement in child score
Time frame: 6 months
1 secondary outcome
Postpone or to overcome liver transplantation complications
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal stem cell transplantation in people with Liver Cirrhosis, run by Assiut University.
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 6 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 25 Oct 2016. 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?
Contact Doaa Abdellah, MSc (00201003669941, doaaabdeltawab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of liver function in form of improvement in child score (time frame: 6 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 25 Oct 2016.