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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. Read our disclaimer for details. Identifier: NCT01332006
Recruitment Status : Unknown
Verified November 2018 by Domenico Russo, Università degli Studi di Brescia.
Recruitment status was:  Recruiting
First Posted : April 8, 2011
Last Update Posted : November 13, 2018
Information provided by (Responsible Party):
Domenico Russo, Università degli Studi di Brescia

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-bone Cord Blood Transplantation for Hematological Malignancies Lacking a HLA Suitable Donor
Study Start Date : November 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Proportion of transplanted patients with successful engraftment at day +30 [ Time Frame: 30 days post transplantation ]

Secondary Outcome Measures :
  1. Clinical response with the analysis of global survival, survival without relapse, relapse incidence [ Time Frame: 3 years from transplantation ]
  2. Infections' Incidence [ Time Frame: One year after transplantation ]
  3. Chimerism monitoring on selected cell populations [ Time Frame: Every three months and until one year after transplantation ]
  4. Immunological reconstitution [ Time Frame: One year after transplantation ]
  5. Acute an Chronic GVHD [ Time Frame: One year after transplantation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01332006

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Contact: Prof Domenico Russo, Full Professor +39/030/3996812

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USD TMO Adulti, Piazzale Spedali Civili Recruiting
Brescia, Italy, 25100
Contact: Michele Malagola, Medical Doctor    +39/030/3996811   
Sponsors and Collaborators
Università degli Studi di Brescia
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Principal Investigator: Domenico Russo, Full Professor USD TMO Adulti
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Responsible Party: Domenico Russo, Director, Università degli Studi di Brescia Identifier: NCT01332006    
Other Study ID Numbers: IBMCB - BS study
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: November 13, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases