Using Autologous Bone Marrow Cells With Wharton Gel Exosomes to Stimulate Hepatic Cell Repair in Liver Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Bone Marrow Aspirate Concentrate.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis. Basic parameters: up to 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A New Regenerative Medicine Protocol Using Autologous Bone Marrow Mononuclear Cells With Growth Factors to Treat Liver Cirrhosis
Overview
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.
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 .
Interventions
- Procedure Autologous Bone Marrow Aspirate Concentrate
using autologous bone marrow aspirated from iliac crest ,centrifuged and then injected intravenously
Primary outcome measures
- child-Pugh score for liver cirrhosis [Time frame: 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]
Eligibility criteria
Inclusion Criteria: any patient with liver cirrhosis , less than 80 years of age -
Exclusion criteria
- active malignancy.
- severe sepsis.
- pregnancy. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Iraq · 1 center
- Capital Private Hospital Alrabee Street — Baghdad
Identifiers
NCT: NCT07374185 · Ifaa-stem protocol