Intra-bone Cord Blood Transplantation

NCT ID: NCT01332006

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2019-12-31

Brief Summary

For the great majority of hematological malignancies, hemopoietic stem cell (HSC) transplant is the only possible cure. The source of HSC is usually bone marrow (BM) or peripheral blood cell (PBSC) mobilized by granulocyte growth factor. Transplant needs a HLA compatible donor weather related or unrelated. A suitable compatible donor can be found in at least 70% of the patients. Thus, at least 30% of patients with indication for allogeneic HSC transplant are not able to undergo the procedure because of the lack of a HLA compatible donor. Cord blood (CB) cells represent another possible source, that needs a lower degree of HLA compatibility. CB transplant, however, offers a lower number of HSC. Thus, adult patient rarely may benefit from this source of stem cells, mainly beacuse thie body weight is too high to have ad adequate number of cell per kg. Recently, experimental animal models confirmed that an adequate recovery of allogeneic hemopoiesis can be achieved via intrabone injection, using a 1Log lower number of cells compared to the intravenous way (Yahata 2003, Castello 2004). Safety and feasibility of intrabone infusion was verified by two clinical studies on humans: the first was conducted by Ringden O. et al. in 18 patients using BM as a source of SC. No side effects and complete engraftment of donor hemopoiesis was observed; the second one was conducted by Frassoni et al. (Frassoni 2008) with CB as the source of HSC.

The aim of this study is to evaluate the intrabone infusion of compatible CB in patients with haematological malignancies lacking a HLA matched donor.

We will perform:

evaluation of the engraftment kinetics; evaluation of the chimerism degree at 30, 60, 100 days, 6 months and 1 year after transplant; studies on immunological reconstitution and the role of the NK compartment.

Conditions

Hematologic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-bone injection

Intra-bone transplantation of hematopoietic stem cells from cord blood

Group Type: EXPERIMENTAL

Intrabone injection

Intervention Type: PROCEDURE

All adults patients with hematological malignancies, lacking a HLA matched donor fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB.

Intra-bone cord blood hematopoietic stem cell transplantation

Intervention Type: BIOLOGICAL

Intra-bone cord blood hematopoietic stem cell transplantation

Intervention Type: BIOLOGICAL

Intra-bone injection of CB hematopoietic SCs after conditioning regimen

Interventions

Intrabone injection

All adults patients with hematological malignancies, lacking a HLA matched donor fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB.

Intervention Type: PROCEDURE

Intra-bone cord blood hematopoietic stem cell transplantation

Intervention Type: BIOLOGICAL

Intra-bone cord blood hematopoietic stem cell transplantation

Intra-bone injection of CB hematopoietic SCs after conditioning regimen

Intervention Type: BIOLOGICAL

Other Intervention Names

Intrabone Transplant; No other name

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 65 years.
• Patients affected by hematological malignancies without a HLA identical sibling donor or unrelated donor.
• Informed consent.

Exclusion Criteria

• Patients with ECOG < 2.
• Patients with blood creatine > 2 mg/dl or with transaminase or cholestase index > 5 times compared to normality upper limits.
• Patients with Cardiac Fraction Ejection < 40%.
• Patients with DLCO < 60% or Diffusing Lung Capacity of carbon monoxide attesting a severe pulmonary insufficiency.
• Patients with peripheral blast cell count over 10%.
• Second neoplasia diagnosed no more than 2 years before.
• Patients with active or suspected infection by fungi for which a therapeutic treatment is ongoing.
• HIV positive patients.
• HCV-RNA and HBV-DNA positive patients
• Pregnant or lactating women.
• Severe mental diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Domenico Russo

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Domenico Russo, Full Professor

Role: PRINCIPAL_INVESTIGATOR

USD TMO Adulti

Locations

USD TMO Adulti, Piazzale Spedali Civili

Brescia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Prof Domenico Russo, Full Professor

Role: CONTACT

russo@med.unibs.it

+39/030/3996812

Facility Contacts

Michele Malagola, Medical Doctor

Role: primary

malagola@med.unibs.it

+39/030/3996811

Other Identifiers

IBMCB - BS study

Identifier Type: -

Identifier Source: org_study_id