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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 80
SponsorGlobal Stem Cell Center, Baghdad

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

active malignancy.

severe sepsis.

pregnancy. -

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous Bone Marrow Aspirate Concentrate

    Procedure/Surgery

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: active treatment cellular product armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 weeks up to 12 months
2

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

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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