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Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

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ClinicalTrials.gov Identifier: NCT01613066
Recruitment Status : Unknown
Verified June 2012 by Roberto Sorasio, Ospedale Santa Croce-Carle Cuneo.
Recruitment status was:  Recruiting
First Posted : June 6, 2012
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
Roberto Sorasio, Ospedale Santa Croce-Carle Cuneo

Brief Summary:
Cord blood (CB) from an unrelated donor is increasingly used an alternative source of hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched donor. However, the utilization of single-unit CB for transplantation of adult patients has been impeded by the low number of nucleated cells available from individual CB units. Direct intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult patients with advanced or high-risk hematological malignancies

Condition or disease Intervention/treatment Phase
High Risk Haematological Malignancies Advanced Haematological Malignancies Procedure: Intrabone Allogeneic Transplant Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies
Study Start Date : November 2008
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: Treatment
Patients with high risk haematological malignancies
Procedure: Intrabone Allogeneic Transplant
Unrelated single unit intrabone cord blood transplantation



Primary Outcome Measures :
  1. Time to neutrophil recovery [ Time Frame: 28 days after transplantation ]

Secondary Outcome Measures :
  1. Incidence of platelet engraftment [ Time Frame: 100 days after transplantation ]
  2. Acute graft versus host disease [ Time Frame: 100 days after transplantation ]
  3. Chronic Graft Versus Host Disease [ Time Frame: One year after transplantation ]
  4. Overall Survival [ Time Frame: One year after transplantation ]


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

Inclusion Criteria:

  • Advanced or High Risk Haematological Malignancies
  • Age 18-65 years
  • no suitable unrelated HLA-matched donors identified in a clinically useful time-frame
  • Informed consent

Exclusion Criteria:

  • Active infectious disease at inclusion
  • HIV- positivity or active hepatitis infection
  • Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit) at inclusion
  • Impaired renal function (Creatinine-clearance <60 ml/min; Serum Creatinine >1.5 x upper normal limit) at inclusion
  • Psychiatric diseases or conditions that might impair the ability to give informed consent

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 ClinicalTrials.gov identifier (NCT number): NCT01613066


Contacts
Contact: Roberto Sorasio, Head, MD +390171642229 rsorasio@inwind.it
Contact: Daniele Mattei, MD +390171642229 mattei.d@ospedale.cuneo.it

Locations
Italy
Azienda Ospedaliera S Croce e Carle Recruiting
Cuneo, Italy, 12100
Contact: Daniele Mattei, MD    +390171642229    mattei.d@ospedale.cuneo.it   
Contact: Roberto Sorasio, MD    +390171642229    rsorasio@inwind.it   
Principal Investigator: Daniele Mattei, MD         
Sponsors and Collaborators
Ospedale Santa Croce-Carle Cuneo
Investigators
Principal Investigator: Daniele Mattei, MD ASO S Croce e Carle