Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ) | UNKNOWN |
| Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. | OTHER_GOV |
| Financiadora de Estudos e Projetos | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase I clinical study to evaluate feasibility, safety and kinetics of cellular therapy with autologous bone marrow-derived mononuclear cells (BMMC) in patients with liver cirrhosis due to virus C hepatitis. Another aim is to study liver tissue changes induced by the BMMC presence. All the patients have moderate liver disfunction and will be submitted to a liver biopsy before BMMC injection. The cells will be labeled with 99mTc and infused through a peripheral vein. Scintigraphy will be performed 24 hours after infusion.
Patients will be submitted to frequent clinical, laboratorial and image evaluation during a one-year follow-up. A second liver biopsy will be done in the 3rd month after infusion to check histological, cellular and molecular evolutive changes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous bone marrow mononuclear cells infusion | Genetic | At least 100.000.000 autologous BMMC will be infused in a peripheral vein once suspended in albumine during 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function worsening | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Liver related mortality | One year | |
| Hepatocellular carcinoma development accessed by ultrasound and CT scan | One year | |
| BMMC kinetics accessed by total body scintigraphy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guilherme FM Rezende, MD PhD | Contact | 55-21-99976292 | g.rezende@superig.com.br | |
| André Torres, MD | Contact | 55-21-78568495 | torres.alm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Guilherme FM Rezende, MD PhD | Universidade Federal do Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário Clementino Fraga Filho | Recruiting | Rio de Janeiro | Rio de Janeiro | 21914-913 | Brazil |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| Oswaldo Cruz Foundation | OTHER |
| University of Edinburgh | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 hours |
| Liver tissue changes evaluated by histopathology analysis and molecular biology | 10 weeks |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |