Clinical Trial for Evaluation of Treatment With Multiple Infusions of Mononuclear Bone Marrow Cells in Patients With Chronic Liver Diseases
NCT ID: NCT02171949
Last Updated: 2017-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2015-04-30
2019-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control group
No interventions assigned to this group
Bone marrow mononuclear cell therapy
Infusion of bone marrow mononuclear cells.
Patients on this group will receive therapy with mononuclear cells. The cells will be diluted on saline and then injected on the hepatic artery through femoral artery puncture.
Interventions
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Infusion of bone marrow mononuclear cells.
Patients on this group will receive therapy with mononuclear cells. The cells will be diluted on saline and then injected on the hepatic artery through femoral artery puncture.
Eligibility Criteria
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Inclusion Criteria
* Non-participation on the waiting list for liver transplantation or, in case of participation, allocation after the fifth position in the list, for subjects with blood group A or O, and after the third position for subjects with other blood groups;
* Absence of clinical, laboratory and radiological evidence of hepatocellular carcinoma;
* Absence of pregnancy potential or negative pregnancy test for female patients, or impossibility to use a contraception method during the study;
* Permission for doing the puncture of iliac crest after evaluation of pre-anesthetic visit.
Exclusion Criteria
* Sepsis;
* Hepatic encephalopathy detected at the screening tests;
* Budd-Chiari syndrome;
* Severe coagulopathy with INR \> 2,4 or platelet count \< 30.000;
* Presence of malignancies (excluding non-melanoma skin cancer);
* Decompensated heart failure;
* Primary hematologic diseases;
* Renal failure with creatinin \> 2,5mg/dl;
* Coinfection with HIV;
* Pregnancy;
* Dependence of organic medium such as circulatory or ventilatory;
* Any other comorbidity with an impact on the survival in 2 years;
* Participation in other clinical trial.
18 Years
70 Years
ALL
No
Sponsors
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Ministry of Science and Technology, Brazil
OTHER
Ministry of Health, Brazil
OTHER_GOV
Hospital Sao Rafael
OTHER
Responsible Party
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Ricardo Ribeiro dos Santos
PhD
Principal Investigators
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André C Lyra, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital São Rafael
Bruno SF Souza, MD, Msc
Role: STUDY_CHAIR
Hospital São Rafael
Eduardo L Braga, PhD
Role: STUDY_CHAIR
Hospital São Rafael
Lourianne N Cavalcante, PhD
Role: STUDY_CHAIR
Hospital São Rafael
Milena BP Soares, PhD
Role: STUDY_CHAIR
Hospital São Rafael
Ricardo R dos Santos, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital São Rafael
Ticiana F Larocca, MD, Msc
Role: STUDY_CHAIR
Hospital São Rafael
Locations
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Hospital São Rafael
Salvador, Estado de Bahia, Brazil
Countries
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Central Contacts
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Facility Contacts
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André C Lyra, PhD
Role: primary
Other Identifiers
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PCL 03/13
Identifier Type: -
Identifier Source: org_study_id