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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03000296
Other study ID # autocrohnproject1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date December 2024

Study information

Verified date January 2021
Source Beneficência Portuguesa de São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the safety and clinical benefits of a therapeutic approach using the cyclophosphamide (Cy) + thymoglobulin® (ATG) + granulocyte colony-stimulating factor (G-CSF) conditioning regimen followed by autologous hematopoietic stem cell transplantation (HSCT) rescue in the treatment of refractory Crohn's disease. Adverse events, and clinical and endoscopic conditions will be assessed at different short and long-term time points.


Description:

Crohn's disease (CD) is a chronic, refractory inflammatory bowel disease that affects the entire digestive tract associated with intestinal and extra intestinal manifestations or other autoimmune diseases. Conventional therapy for Crohn's disease includes anti-inflammatory, immunosuppressant and/or biologic drugs/corticosteroids. This treatment benefits the majority of patients. However, a proportion of patients fail to achieve complete and long-term disease control and often require multiple intestinal surgeries with a risk of developing short bowel syndrome. Hematopoietic stem cell transplantation (HSCT) has been proposed to cause lymphoablation and reset of the immune system as an alternative strategy to induce long-term disease control in this high-risk population. This study enrolled Crohn's disease patients not responsive to conventional therapy. Initially safety and the clinical outcome will be evaluated. The selected patients will be admitted to the bone marrow transplant (BMT) unit for the mobilization regimen using cyclophosphamide (Cy - 60 mg/kg) and G-CSF (10 mcg/kg/day) from the 5th day after Cy administration until harvesting progenitor cells from peripheral blood by leukapheresis. After seven days of rest, the conditioning regimen consists of Cy (200 mg/kg total dose for four days), rabbit antithymocyte globulin (6.5 mg/kg total dose for four days) and methylprednisolone (500 mg/day). The clinical course of patients with refractory Crohn´s disease will be evaluated to determine the efficacy of HSCT as a therapeutic tool including the adverse aspects of the procedure, clinical outcome and quality of life.


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Study Design


Intervention

Procedure:
Autologous Hematopoietic Stem Cell Transplantation
Hematopoietic stem cell transplantation Lymphoablation followed by hematopoietic stem cell transplantation to rescue the immune system.

Locations

Country Name City State
Brazil Beneficencia Portuguesa Sao Jose do Rio Preto SP

Sponsors (1)

Lead Sponsor Collaborator
Beneficência Portuguesa de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of unselected autologous HSCT in refractory Crohn´s disease patients HHSCT safety will be analyzed by laboratory tests and treatment-related adverse events. Safety will be evaluated by treatment-related adverse events. All adverse events will be recorded in a standardized way and their relationship to the study protocol will be assessed at different short- and long-term time points. 12 months
Secondary Crohn´s Disease Activity Index (CDAI) Duration of disease remission, defined as a CDAI = 150, will be assessed at 1, 3, 6, 12 and 24 months after transplant. 12 months
Secondary CRAIG Crohn´s Severity Score (CSS) The CRAIG CSS will be assessed at 1, 3, 6, 12 and 24 months after transplant. 12 months
Secondary Inflammatory Bowel Disease Questionnaire (IBDQ) The IBDQ will be administered at 1, 3, 6, 12 and 24 months after transplant. 24 months
Secondary Short Form-36 Health Survey (SF-36) The SF-36 will be administered at 1, 3, 6, 12 and 24 months after transplant. 24 months
Secondary Simple Endoscopic Activity Score (SES) The SES will be assessed at 6, 12 and 24 months after HSCT. 24 months
Secondary Crohn's Disease Endoscopic Index of Severity (CDEIS) The CDEIS will be assessed at 6, 12 and 24 months after HSCT. 24 months
Secondary Rutgeerts endoscopic score Rutgeerts endoscopic score will be assessed at 6, 12 and 24 months after HSCT. 24 months
Secondary Harvey & Bradshaw Index (HBI) The HBI will be assessed at 1, 3, 6, 12 and 24 months after HSCT. 24 months
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