Liver RegenerationPhase 1NCT02327832
Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs
A Phase 1 study testing Autologous BMSCs and bone marrow-derived mesenchymal stem cells in people with Liver Regeneration, run by Yamaguchi University Hospital at 1 site in Japan.
Trial summary
Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Liver Regeneration
- What is being tested?
- Autologous BMSCs and bone marrow-derived mesenchymal stem cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2014to Mar 2017
- Phase
- Phase 1
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL,
- Patients who are still deemed unsuitable as a candidate for general anesthesia.
- Patients must provide informed consent for study participation.
Who cannot join
- Patients with a current history of malignant neoplasm.
- Patients with gastroesophageal varices at risk of rupture.
- Patients with renal insufficiency and a serum creatinine ≥2 mg/dL.
- Patients with a hemoglobin <8 g/dL, a platelet count <50,000/μL, or a prothrombin time <40%.
- Patients with a performance status of 3 or 4.
- Patients who refuse to consent to allogeneic blood transfusion.
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- Women who are pregnant.
- Patients whom their attending physician deems are not suitable candidates for general anesthesia.
- Patients with a current or previous severe allergic reaction to a contrast agent, beef, cow milk, and anesthesia.
- Any patient deemed unsuitable for study inclusion by their attending physician.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Department of Gastroenterology and Hepatology Yamaguchi University Graduate School of Medicine
Ube, Yamaguchi, Yamaguchi, 7558505
Taro Takami, MD, PhD, +81836222241, t-takami@yamaguchi-u.ac.jp
Isao Sakaida, MD, PhD
About this study
Official title: Safety Study of a Less Invasive Liver Regeneration Therapy Using Cultured Autologous Bone Marrow-derived Mesenchymal Stem Cells for Compensated Liver Cirrhotic Patient
Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL, patients who are still deemed unsuitable as a candidate for general anesthesia. About 30 mL of autologous bone marrow was collected from the bilateral iliac crests under local anesthesia, heparin was added after collection. In addition, at the Center for Regenerative and Cell Therapy at Yamaguchi University Hospital, a nucleated cell fraction was prepared. Next, a cell suspension was prepared by adding culture medium, and this was inoculated into a culture flask. After subculturing for 3 weeks, the cells were infused through a peripheral vein. The primary endpoint is the incidence of adverse events up to 24 weeks after ABMSC infusion.
- Conditions
- Liver Regeneration
- Being tested
- Autologous BMSCs, bone marrow-derived mesenchymal stem cells
- Keywords
- Confirmation, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous BMSCsProcedure or surgery
Also called BMSC
Cultured autologous bone marrow-derived mesenchymal stem cells
bone marrow-derived mesenchymal stem cellsDrug
| Study group | Role | What they receive |
|---|---|---|
| Autologous BMSCs | Experimental | Infusion of cultured autologous bone marrow derived mesenchymal stem cells Receives: Procedure: Autologous BMSCs; Drug: bone marrow-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events
Measured: up to 24 weeks the infusion
Secondary outcomes (5)
Child-Pugh score
Measured: up to 24 weeks the infusion
Serum albumin levels
Measured: up to 24 weeks the infusion
Serum fibrosis markers
Measured: up to 24 weeks the infusion
Improvement or disappearance of lower extremity edema
Measured: up to 24 weeks the infusion
Subjective symptom scores (SF-36)
Measured: up to 24 weeks the infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver RegenerationStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yamaguchi University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarotakami, Yamaguchi University Hospital
- Investigators
- Isao Sakaida, MD, PhD, Study chair, Yamaguchi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327832
- Sponsor's protocol ID
- ICHINAI-BMSC1
- Status last verified
- Dec 2014
- First submitted
- 24 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of a Less Invasive Liver Regeneration Therapy Using Cultured Autologous Bone Marrow-derived Mesenchymal Stem Cells for Compensated Liver Cirrhotic Patient
- ClinicalTrials.gov ID
- NCT02327832
- Acronym / sponsor ID
- ICHINAI-BMSC1
- Conditions
- Liver Regeneration
- Keywords
- Confirmation, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yamaguchi University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2017 (estimated)
- First posted
- 30 Dec 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.
Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL, patients who are still deemed unsuitable as a candidate for general anesthesia. About 30 mL of autologous bone marrow was collected from the bilateral iliac crests under local anesthesia, heparin was added after collection. In addition, at the Center for Regenerative and Cell Therapy at Yamaguchi University Hospital, a nucleated cell fraction was prepared. Next, a cell suspension was prepared by adding culture medium, and this was inoculated into a culture flask. After subculturing for 3 weeks, the cells were infused through a peripheral vein. The primary endpoint is the incidence of adverse events up to 24 weeks after ABMSC infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous BMSCs | Experimental | Procedure: Autologous BMSCs, Drug: bone marrow-derived mesenchymal stem cellsInfusion of cultured autologous bone marrow derived mesenchymal stem cells |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is <3.0 mg/dL,
- Patients who are still deemed unsuitable as a candidate for general anesthesia.
- Patients must provide informed consent for study participation.
Key exclusion criteria (10 listed)
- Patients with a current history of malignant neoplasm.
- Patients with gastroesophageal varices at risk of rupture.
- Patients with renal insufficiency and a serum creatinine ≥2 mg/dL.
- Patients with a hemoglobin <8 g/dL, a platelet count <50,000/μL, or a prothrombin time <40%.
- Patients with a performance status of 3 or 4.
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 BMSCsAlso: BMSCCultured autologous bone marrow-derived mesenchymal stem cells | Procedure or surgery | Autologous BMSCs |
| bone marrow-derived mesenchymal stem cells | Drug | Autologous BMSCs |
Primary outcome
The incidence of adverse events
Time frame: up to 24 weeks the infusion
5 secondary outcomes
Child-Pugh score
Time frame: up to 24 weeks the infusion
Serum albumin levels
Time frame: up to 24 weeks the infusion
Serum fibrosis markers
Time frame: up to 24 weeks the infusion
Improvement or disappearance of lower extremity edema
Time frame: up to 24 weeks the infusion
Subjective symptom scores (SF-36)
Time frame: up to 24 weeks the infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
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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.
Isao Sakaida, MD, PhD study chair
Yamaguchi University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous BMSCs and bone marrow-derived mesenchymal stem cells in people with Liver Regeneration, run by Yamaguchi University Hospital at 1 site in Japan.
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 3 inclusion and 10 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 30 Dec 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 Japan. 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 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.
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 Taro Takami, MD, PhD (+81836222241, naika1_w@yamaguchi-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (time frame: up to 24 weeks the infusion). 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 30 Dec 2014.