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

Global Stem Cell Center, Baghdad

Status: Begins enrollment this month

Conditions: Liver Cirrhosis

Treatments: Procedure: Autologous Bone Marrow Aspirate Concentrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT07374185

Ifaa-stem protocol

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 10 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

active treatment cellular product arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Autologous Bone Marrow Aspirate Concentrate