Using Autologous Bone Marrow Cells With Wharton Gel Exosomes to Stimulate Hepatic Cell Repair in Liver Cirrhosis

NCT07374185 | Not Yet Recruiting DMC

• 1 other identifier: Ifaa-stem protocol
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

the study includes patients with liver cirrhosis irrespective of the stage excluding people with active tumor or other major health issue endangering life, the protocol includes the use of autologous bone marrow derived mononuclear cells harvested from the same patient under local anesthesia ,followed by cell concentration and viability testing , then final product is combined with small volume of 2 cc of Wharton gel exosomes 20 billion per to be administered intravenously.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

• child-Pugh score for liver cirrhosis

  The Child-Pugh score is a clinical tool used to assess the severity and prognosis of chronic liver disease, especially cirrhosis, by evaluating five key factors: total bilirubin, albumin, INR (prothrombin time), ascites, and hepatic encephalopathy, with each getting 1-3 points (1=best, 3=worst). Summing these points categorizes patients into Class A (5-6 points, well-compensated), B (7-9 points, moderately impaired), or C (10-15 points, severe dysfunction), helping guide treatment, predict surgical risk, and manage liver transplant needs. A is minimum and C maximum

  12 weeks up to 12 months

• child-Pugh score of 3 stages depends on bilirubin level, serum albumin ,prothrombin time ,ascites ,encephalopathy

  measurement of prothrombin time, albumin, serum bilirubin level and assess ascites and hepatic encephalopathy

  12 months

Study Arms (1)

active treatment cellular product arm

ACTIVE COMPARATOR

autologous bone marrow aspiration is done under sedation with the addition of Wharton gel 2 cc exosomes then given intravenously after using 170 micron filter.

Procedure: Autologous Bone Marrow Aspirate Concentrate

Interventions

Autologous Bone Marrow Aspirate Concentrate PROCEDURE

using autologous bone marrow aspirated from iliac crest ,centrifuged and then injected intravenously

active treatment cellular product arm

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• active malignancy.
• severe sepsis.
• pregnancy. -

Sponsors & Collaborators

• Global Stem Cell Center, Baghdad: lead

Study Sites (1)

Capital Private Hospital Alrabee Street

Baghdad, Iraq, 964, Iraq

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

abdulmajeed hammadi

CONTACT

+9647902268105; hammadimajeed@gmail.com

khalil juma kareem kareem

CONTACT

+9647803977072; hammadimajeed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 10 cases liver cirrhosis regardless of the stage to be treated with autologous cells

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: January 28, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)