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Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs

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ClinicalTrials.gov Identifier: NCT02327832
Recruitment Status : Unknown
Verified December 2014 by tarotakami, Yamaguchi University Hospital.
Recruitment status was:  Recruiting
First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
tarotakami, Yamaguchi University Hospital

Tracking Information
First Submitted Date  ICMJE December 24, 2014
First Posted Date  ICMJE December 30, 2014
Last Update Posted Date December 30, 2014
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
The incidence of adverse events [ Time Frame: up to 24 weeks the infusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs
Official Title  ICMJE Safety Study of a Less Invasive Liver Regeneration Therapy Using Cultured Autologous Bone Marrow-derived Mesenchymal Stem Cells for Compensated Liver Cirrhotic Patient
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Regeneration
Intervention  ICMJE
  • Procedure: Autologous BMSCs
    Cultured autologous bone marrow-derived mesenchymal stem cells
    Other Name: BMSC
  • Drug: bone marrow-derived mesenchymal stem cells
Study Arms  ICMJE Experimental: Autologous BMSCs
Infusion of cultured autologous bone marrow derived mesenchymal stem cells
Interventions:
  • Procedure: Autologous BMSCs
  • Drug: bone marrow-derived mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 29, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02327832
Other Study ID Numbers  ICMJE ICHINAI-BMSC1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party tarotakami, Yamaguchi University Hospital
Study Sponsor  ICMJE Yamaguchi University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Isao Sakaida, MD, PhD Yamaguchi University Hospital
PRS Account Yamaguchi University Hospital
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP