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Intra-bone Cord Blood Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01332006
Recruitment Status : Recruiting
First Posted : April 8, 2011
Last Update Posted : November 12, 2018
Information provided by (Responsible Party):
Domenico Russo, Università degli Studi di Brescia

Tracking Information
First Submitted Date  ICMJE April 6, 2011
First Posted Date  ICMJE April 8, 2011
Last Update Posted Date November 12, 2018
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2011)
Proportion of transplanted patients with successful engraftment at day +30 [ Time Frame: 30 days post transplantation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01332006 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2011)
  • Clinical response with the analysis of global survival, survival without relapse, relapse incidence [ Time Frame: 3 years from transplantation ]
  • Infections' Incidence [ Time Frame: One year after transplantation ]
  • Chimerism monitoring on selected cell populations [ Time Frame: Every three months and until one year after transplantation ]
  • Immunological reconstitution [ Time Frame: One year after transplantation ]
  • Acute an Chronic GVHD [ Time Frame: One year after transplantation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Intra-bone Cord Blood Transplantation
Official Title  ICMJE Intra-bone Cord Blood Transplantation for Hematological Malignancies Lacking a HLA Suitable Donor
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hematologic Neoplasms
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Intra-bone injection
Intra-bone transplantation of hematopoietic stem cells from cord blood
  • Procedure: Intrabone injection
  • Biological: Intra-bone cord blood hematopoietic stem cell transplantation
  • Biological: Intra-bone cord blood hematopoietic stem cell transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 7, 2011)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Prof Domenico Russo, Full Professor +39/030/3996812
Listed Location Countries  ICMJE Italy
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01332006
Other Study ID Numbers  ICMJE IBMCB - BS study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Domenico Russo, Università degli Studi di Brescia
Study Sponsor  ICMJE Università degli Studi di Brescia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Domenico Russo, Full Professor USD TMO Adulti
PRS Account Università degli Studi di Brescia
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP