Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients
Launched by ROYAN INSTITUTE · May 8, 2010
Trial Information
Current as of June 02, 2025
Completed
Keywords
ClinConnect Summary
BM Aspiration will be done twice (3months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For separation of CD133+ cells the CliniMACS instrument will be used. Cells are injected twice (3months interval) via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 mo...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 16-65 Years cirrhotic patient
- • Approved cirrhosis by elastografy ,biopsy, sonography
- • Serum ALT 1/5 times more than normal
- • MELD score 12 or Child score B or C
- Exclusion Criteria:
- • Portal vein thrombosis
- • Hepatic encephalopathy, score 3\&4
- • ALT \& AST 3times more than normal
- • Serum Cr more than 1/5mg/dL
- • (Anti-HIV +) (Anti-HCV+) (HBS-Ag+)
- • Hepatocel carcinoma
- • Primary sclerosing cholangitis (PSC)
- • Esophageal varices grade 4
- • Addiction
About Royan Institute
The Royan Institute is a leading research organization dedicated to advancing the fields of reproductive health, stem cell biology, and regenerative medicine. Established to promote scientific innovation and clinical applications, the Institute focuses on translating cutting-edge research into therapeutic solutions. With a strong commitment to ethical practices and collaboration, Royan Institute conducts rigorous clinical trials aimed at improving patient outcomes and enhancing healthcare practices globally. Through its multidisciplinary approach and state-of-the-art facilities, the Institute strives to push the boundaries of medical science and contribute significantly to the understanding and treatment of complex health issues.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tehran, , Iran, Islamic Republic Of
Patients applied
Trial Officials
Hamid Gourabi, PhD
Study Chair
Royan Institute
Reza Malekzadeh, MD
Study Chair
Gastroenterology and hepatic disease research center
Hossein Baharvand, PhD
Principal Investigator
Royan Institute
Mohammad Bagheri, MD
Principal Investigator
Gastroenterology and hepatic disease research center
Massoud Vosough, MD
Study Director
Royan Institute
Nasser Aghdami, MD., PhD
Principal Investigator
Royan Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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