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

January 23, 2026 updated by: Global Stem Cell Center, Baghdad

A New Regenerative Medicine Protocol Using Autologous Bone Marrow Mononuclear Cells With Growth Factors to Treat Liver Cirrhosis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Mesenchymal stem cell therapy is one option that can help in improving liver functions if given parenteral, those mesenchymal stem cells can be harvested from different sources ,regarding this trial investigators use bone marrow derived mononuclear cells taken from posterior crest of iliac bone of the same patient, the bone marrow volume taken is around 50 cubic milliliter to be followed by filtration to get rid of bone fragments then Wharton gel exosomes are added in 2 cc volume and total 20 billion particles ,the product is administered intravenously .

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: any patient with liver cirrhosis , less than 80 years of age -

Exclusion Criteria:

  1. active malignancy.
  2. severe sepsis.
  3. pregnancy. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: active treatment cellular product arm
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
using autologous bone marrow aspirated from iliac crest ,centrifuged and then injected intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
child-Pugh score for liver cirrhosis
Time Frame: 12 weeks up to 12 months
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
Time Frame: 12 months
measurement of prothrombin time, albumin, serum bilirubin level and assess ascites and hepatic encephalopathy
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Global Stem Cell Center, Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2026

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ifaa-stem protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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