A safety and efficacy study of autologous bone marrow cell transplantation for HIV positive patients with cirrhosis

A safety and efficacy study of autologous bone marrow cell transplantation for HIV positive patients with cirrhosis - ABMi liver regeneration project

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005174

Enrollment

Registered

2011-03-02

Start date

2011-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection, AIDS, Cirrhosis

Interventions

Autologous bone marrow transplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Outpatients or inpatients that are treated for HIV infection at AIDS Clinical Center of National Center for Global Health and Medicine and: 1) between 20 and 70 of age 2) have cirrhosis with 7 or higher Child-Pugh Score in Child-Pugh Score B 3) able to consent and willing to participate in the study 4) under good control for HIV

Exclusion criteria

Exclusion criteria: Cases applicable to ANY condition of the following: 1) Hepatocellular carcinoma (HCC), except for cases having been treated completely without history of recurrence 2) Malignant tumor other than HCC 3) Alcoholic liver disease (ALD) 4) Hemoglobin under 8g/dL or Platelets under 20/ml at the registration 5) Esophageal or gastric varices with a risk of bursting, except for cases only with cured history of such conditions 6) Cases that cannot obtain the informed consent to autologous blood transfusion 7) Pregnancy 8) Renal dysfunction with 2mg/dL or higher serum creatinine 9) Performance Status 3 or 4 (assessment excludes hemophilic arthritis related daily life limitations) 10) not fit for general anesthesia 11) other conditions that doctor considered not suitable for the study

Design outcomes

Primary

Measure	Time frame
The primary outcomes are treatment safety and efficacy at the point of 24 weeks after the transplantation: For Child-Pugh Score, -2 reduction or more as "improvement", change range within 1 as "no change", +2 increase or more as "worsening", respectively from the score before the transplantation. Also evaluate statistical significance between pre-transplantation and 24 weeks after. For serum albumin and fibrosis markers, 10% changes before and after as "improvement" or "worsening". Evaluate statistical significance of albumin and Transient Elastography between the pre-transplantation and the 24 weeks after. For image evaluation, three degrees of ascites [none, mild, severe] as in Child-Pugh Score with "improvement" as one or more degree improvement. For self-reporting subjective symptoms, compare bottom-line scores of each sub-categorical scale in SF health score card. Because cirrhosis is a progressive condition, treatment efficacy is defined by "improvement" and "no change" from the above.	—

Measure

Time frame

The primary outcomes are treatment safety and efficacy at the point of 24 weeks after the transplantation: For Child-Pugh Score, -2 reduction or more as "improvement", change range within 1 as "no change", +2 increase or more as "worsening", respectively from the score before the transplantation. Also evaluate statistical significance between pre-transplantation and 24 weeks after. For serum albumin and fibrosis markers, 10% changes before and after as "improvement" or "worsening". Evaluate statistical significance of albumin and Transient Elastography between the pre-transplantation and the 24 weeks after. For image evaluation, three degrees of ascites [none, mild, severe] as in Child-Pugh Score with "improvement" as one or more degree improvement. For self-reporting subjective symptoms, compare bottom-line scores of each sub-categorical scale in SF health score card. Because cirrhosis is a progressive condition, treatment efficacy is defined by "improvement" and "no change" from the above.

—

Secondary

Measure	Time frame
The key secondary outcomes is the duration of the treatment effectiveness. Using the same evaluation modules as of the primary outcomes, investigate and assess the chronological effectivity after the primal 24 weeks up to 48 weeks to evaluate the duration of the treatment efficacy.	—

Countries

Japan

Contacts

Public ContactKunihisa Tsukada

National Center for Global Health and Medicine AIDS Clinical Center

ktsukada@acc.ncgm.go.jp03-3202-7181(5369)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026