Hepatic Cirrhosis Clinical Trial
Official title:
Randomized, Open and Controlled Clinical Trial for Evaluation of Treatment With Multiple Infusions of Mononuclear Bone Marrow Cells in Patients With Chronic Liver Diseases
The purpose of this study is to evaluate the safety and efficacy of multiple infusions of mononuclear bone marrow cells in patients with chronic liver diseases.
This is a safety/efficacy phase II, open, randomized, controlled clinical trial, with two
arms. The study population will consist of 30 patients with chronic decompensated liver
disease (Child-Pugh B or C). The candidates included in the study will be asked to
voluntarily participate and sign the written consent.
The patients will be allocated randomly into 2 groups: in group A, the patients will undergo
the intervention; and in group B, the patients will be the controls. Patients of both groups
will receive clinical follow-up. They will be maintained on drug therapy commonly used in
patients with cirrhosis, which may include: spironolactone, furosemide, lactulose,
metronidazole, neomycin, analogs of nucleoside / nucleotide in patients with hepatitis B, and
vitamin complexes.
All patients included in Group A will undergo cell therapy according to the technique
described as follows: on day 1 (D-1), patients will be hospitalized to undergo the bone
marrow puncture through the iliac crest. 150 to 200 ml of bone marrow aspirate will be
collected. The procedure will be done under local anesthesia and sedation. The fraction of
mononuclear cells will be isolated from the aspirated marrow by the SEPAX (System of cell
processing) - Biosafe, Switzerland.
The enriched fraction of collected mononuclear cells will be resuspended in saline. The
obtained cell populations will be analyzed by flow cytometry for its characterization, and
then diluted in 20 ml saline. The cells will be injected 3 times throughout the study, on
days 1 (D-1), 30 (D-30) and 60 (D-60).
Patients will undergo a series of clinical and laboratory evaluations and will also be
submitted to the following procedures:
- Cell blood count
- Biochemical analysis (measurement of electrolytes - sodium and potassium)
- Renal function tests (urea and creatinine)
- Liver profile tests (total proteins and fractions, bilirubin, prothrombin time,
transaminases, alkaline phosphatase, gamma-GT)
- Metabolic profile (glucose, total cholesterol and fractions, triglycerides)
- Thyroid profile tests
- Serology required for blood transfusion and bone marrow transplant in Brazil
- Alpha-fetoprotein
- Beta-HCG (human chorionic gonadotropin), for women
- Handgrip dynamometer
- Treadmill test
- Six-minute walk test
- Abdomen doppler ultrasound
- Magnetic resonance imaging of the upper abdomen with elastography
- Measurement of serum factors
- Shear wave elastography
Also, the patients will respond to questions from the SF (Short Form) -36 questionnaire (for
assessment of quality of life).
Clinical follow-up will be kept for patients who suspend their participation in the study for
any adverse event and / or laboratory abnormality, or for the patient's own desire, following
insurance protocols. In addition to the clinical and surgical follow-up, specific medical
care will be offered to patients who experience adverse events, until stabilization of the
patient, even if the target date for completion of the study has been exceeded.
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