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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

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.

Condition or disease Intervention/treatment Phase
Liver Regeneration Procedure: Autologous BMSCs Drug: bone marrow-derived mesenchymal stem cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2014
Estimated Primary Completion Date : March 2017

Arm Intervention/treatment
Experimental: Autologous BMSCs
Infusion of cultured autologous bone marrow derived mesenchymal stem cells
Procedure: Autologous BMSCs
Cultured autologous bone marrow-derived mesenchymal stem cells
Other Name: BMSC

Drug: bone marrow-derived mesenchymal stem cells



Primary Outcome Measures :
  1. The incidence of adverse events [ Time Frame: up to 24 weeks the infusion ]

Secondary Outcome Measures :
  1. Child-Pugh score [ Time Frame: up to 24 weeks the infusion ]
  2. Serum albumin levels [ Time Frame: up to 24 weeks the infusion ]
  3. Serum fibrosis markers [ Time Frame: up to 24 weeks the infusion ]
  4. Improvement or disappearance of lower extremity edema [ Time Frame: up to 24 weeks the infusion ]
  5. Subjective symptom scores (SF-36) [ Time Frame: up to 24 weeks the infusion ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327832


Contacts
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Contact: Taro Takami, MD, PhD +81836222241 naika1_w@yamaguchi-u.ac.jp

Locations
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Japan
Department of Gastroenterology and Hepatology Yamaguchi University Graduate School of Medicine Recruiting
Ube, Yamaguchi, Yamaguchi, Japan, 7558505
Contact: Taro Takami, MD, PhD    +81836222241    t-takami@yamaguchi-u.ac.jp   
Principal Investigator: Isao Sakaida, MD, PhD         
Sponsors and Collaborators
Yamaguchi University Hospital
Investigators
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Study Chair: Isao Sakaida, MD, PhD Yamaguchi University Hospital

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Responsible Party: tarotakami, MD, PhD, Yamaguchi University Hospital
ClinicalTrials.gov Identifier: NCT02327832     History of Changes
Other Study ID Numbers: ICHINAI-BMSC1
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by tarotakami, Yamaguchi University Hospital:
Confirmation
safety