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NCT Number: NCT07374185

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

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Key information

Conditions

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

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Autologous Bone Marrow Aspirate Concentrate

Procedure

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

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

abdulmajeed hammadi

CONTACT

[email protected]

+9647902268105

khalil juma kareem kareem

CONTACT

[email protected]

+9647803977072

Sponsors and collaborators

Lead sponsor

Global Stem Cell Center, Baghdad

Industry

Registry information

Official study title

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

Acronym: bone marrow

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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