Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)
This study is not yet open for participant recruitment.
Verified December 2012 by Sheba Medical Center
Sponsor:
Dr. Avichai Shimoni MD
Collaborator:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Information provided by (Responsible Party):
Dr. Avichai Shimoni MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01235468
First received: November 2, 2010
Last updated: December 1, 2012
Last verified: December 2012
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Purpose
The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Umbilical Cord Blood Stem Cell Transplantation Hematological Malignancies |
Biological: ex vivo expansion |
Phase 1 |
| 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: | Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders |
Resource links provided by NLM:
Further study details as provided by Sheba Medical Center:
Primary Outcome Measures:
- Safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Number of patients with adverse events during infusion
- engraftment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Time to engraftment
- treatment-related toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Type and severity of adverse events after transplantation using the NCI CTC scale
- GVHD [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Number of patients with acute and chronic GVHD after transplantation
Secondary Outcome Measures:
- Immunological reconstruction [ Time Frame: 5 years ] [ Designated as safety issue: No ]immunological reconstruction after transplantation measured by lymphocyte number and function
- relapse [ Time Frame: 5 years ] [ Designated as safety issue: No ]rate of disease recurrence
| Estimated Enrollment: | 10 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CB expnasion
ex-vivo expansion of cord blood for transplantation
|
Biological: ex vivo expansion
ex-vivo expansion of cord blood for transplantation
|
Detailed Description:
Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age > 18 years
- hematological malignancy
- standard indication for allogeneic transplantation
- expected survival time over 12 weeks
- no related or unrelated donor
- availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight
Exclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status >2
- Prior allogeneic transplantation
- Pregnant or nursing women
- Positive serology for hepatitis B or C
- HIV positive
- Left ventricular ejection fraction < 50%
- DLCO < 50%
- Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study
- Treatment with other investigational drugs within 4 weeks of enrolling in this protocol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235468
Contacts
| Contact: Arnon Nagler, MD | 972 3 530 5830 | a.nagler@sheba.health.gov.il |
| Contact: Avichai Shimoni, MD | 972 3 530 5303 | ashimoni@sheba.health.gov.il |
Locations
| Israel | |
| Chaim Sheba Medical Center | Not yet recruiting |
| Tel-Hashomer, Israel, 52621 | |
| Contact: Arnon Nagler, MD 972 3 530 5830 a.nagler@sheba.health.gov.il | |
| Contact: Avichai Shimoni 972 3 530 5303 ashimoni@sheba.health.gov.il | |
| Principal Investigator: Arnon Nagler, MD | |
| Italy | |
| Fondazione Ospedale Maggiore Policlinico | Not yet recruiting |
| Milano, Italy, 20122 | |
| Contact: Rosaria Giordano, MD 39 02 5503 4053 | |
| Principal Investigator: Rosaria Giordano, mMD | |
Sponsors and Collaborators
Dr. Avichai Shimoni MD
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
| Principal Investigator: | Arnon Nagler, MD | Chaim Sheba Medical Center |
More Information
No publications provided
| Responsible Party: | Dr. Avichai Shimoni MD, Dr. Avichai Shimoni, hematologist, Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT01235468 History of Changes |
| Other Study ID Numbers: | SHEBA-10-7959-AN-CTIL |
| Study First Received: | November 2, 2010 |
| Last Updated: | December 1, 2012 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
umbilical cord blood ex vivo expansion engraftment GVHD |
Additional relevant MeSH terms:
|
Neoplasms Hematologic Diseases Hematologic Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 23, 2013