Intra-bone Cord Blood Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Università degli Studi di Brescia
Sponsor:
Information provided by (Responsible Party):
Domenico Russo, Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT01332006
First received: April 6, 2011
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Hematologic Neoplasms
Procedure: Intrabone injection
Biological: Intra-bone cord blood hematopoietic stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-bone Cord Blood Transplantation for Hematological Malignancies Lacking a HLA Suitable Donor

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Brescia:

Primary Outcome Measures:
  • Proportion of transplanted patients with successful engraftment at day +30 [ Time Frame: 30 days post transplantation ] [ Designated as safety issue: Yes ]
    Engraftment


Secondary Outcome Measures:
  • Clinical response with the analysis of global survival, survival without relapse, relapse incidence [ Time Frame: 3 years from transplantation ] [ Designated as safety issue: No ]
  • Infections' Incidence [ Time Frame: One year after transplantation ] [ Designated as safety issue: Yes ]
  • Chimerism monitoring on selected cell populations [ Time Frame: Every three months and until one year after transplantation ] [ Designated as safety issue: No ]
  • Immunological reconstitution [ Time Frame: One year after transplantation ] [ Designated as safety issue: Yes ]
  • Acute an Chronic GVHD [ Time Frame: One year after transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 17
Study Start Date: November 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-bone injection
Intra-bone transplantation of hematopoietic stem cells from cord blood
Procedure: 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.
Other Name: Intrabone Transplant
Biological: Intra-bone cord blood hematopoietic stem cell transplantation Biological: Intra-bone cord blood hematopoietic stem cell transplantation
Intra-bone injection of CB hematopoietic SCs after conditioning regimen
Other Name: No other name

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332006

Contacts
Contact: Prof Domenico Russo, Full Professor +39/030/3996812 russo@med.unibs.it

Locations
Italy
USD TMO Adulti, Piazzale Spedali Civili Recruiting
Brescia, Italy, 25100
Contact: Michele Malagola, Medical Doctor    +39/030/3996811    malagola@med.unibs.it   
Sponsors and Collaborators
Università degli Studi di Brescia
Investigators
Principal Investigator: Domenico Russo, Full Professor USD TMO Adulti
  More Information

No publications provided

Responsible Party: Domenico Russo, Director, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT01332006     History of Changes
Other Study ID Numbers: IBMCB - BS study
Study First Received: April 6, 2011
Last Updated: April 5, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014