HIV Liver Regeneration Project for HIV Patients With Cirrhosis by Autologous Bone Marrow Transplantation (HIV-ABMi)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01309594|
Recruitment Status : Unknown
Verified September 2014 by National Center for Global Health and Medicine, Japan.
Recruitment status was: Enrolling by invitation
First Posted : March 7, 2011
Last Update Posted : September 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection AIDS Cirrhosis||Procedure: Hematopoietic stem cell transplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety and Efficacy Study of Autologous Bone Marrow Cell Infusion Therapy in HIV Infected Patients With Advanced Liver Cirrhosis|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
Experimental: Hematopoietic stem cell transplantation
Extraction of bone marrow cells from HIV positive patients with advanced liver cirrhosis and transplant their bone marrow back into the patients
Procedure: Hematopoietic stem cell transplantation
Harvest and apheresis of bone marrow cells from HIV infected patients with cirrhosis under general anesthesia, using bone marrow collection system and transplanting the patients' hematopoietic stem cells back to the patients
Other Name: Autologous bone marrow cell infusion therapy (ABMi)
- Post-transplantation prognosis for cirrhosis [ Time Frame: 24 weeks ]
Evaluate statistical significance between pre-transplantation and 24 weeks after in:
- Child-Pugh score
- serum fibrosis markers
- Transient Elastography (TM)
- ascites imagery
- SF-36v2(TM) Health Survey.
Because advanced liver cirrhosis is a progressive condition itself, treatment efficacy is defined by "improvement" and "no change" in the indicators listed.
- Duration of the treatment efficacy [ Time Frame: After 24 weeks up to 48 weeks ]Using the same evaluation modules as of the primary outcomes, investigate and assess the autologous bone marrow transplantation effectivity chronologically after the primal 24 weeks up to 48 weeks to evaluate the duration of the treatment efficacy.
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): NCT01309594
|National Center for Global Health and Medicine|
|Shinjuku, Tokyo, Japan, 1628655|
|Principal Investigator:||Shinichi Oka, MD PhD||National Center for Global Health and Medicine|