- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01816230
Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM
Allogeneic Stem Cell Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells, in Adolescent and Adult Patients With Hematological Malignancies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Umbilical cord blood (UCB) is an alternative stem cell source for hematopoietic stem cell transplantations (HSCT) and can be used for the treatment of various life-threatening diseases, such as hematological malignancies or genetic blood disorders, in such cases where a matched related stem cell donor is not available. However, the major drawback of using this valuable stem cells source is the limited cell dose in a single cord blood unit (CBU), which was shown to be associated with inadequate hematopoietic reconstitution and high risk of transplant-related mortality. To improve outcomes and extend applicability of UCB transplantation, one potential solution is ex vivo expansion of UCB-derived stem and progenitor cells. NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells. NiCord® is based on a novel technology for the ex vivo cell expansion of cord blood derived hematopoietic progenitor cells. By increasing the number of the short and long-term reconstitution progenitor cells transplanted, NiCord® has the potential to enable the broader application of UCB transplantation, and improve the clinical outcomes of UCB transplantation.
The study is designed as a multi center, single arm study, evaluating the safety and efficacy of the transplantation of NiCord® to patients with hematological malignancies following myeloablative therapy.
Total study duration is approximately 400 days from the signing of informed consent to the last visit one year following transplantation
The overall study objective is to evaluate the safety and efficacy of NiCord®: single ex-vivo expanded cord blood unit transplantation in patients with hematological malignancies following myeloablative therapy as follows:
The main study objectives are to assess the cumulative incidence of patients with NiCord®-derived neutrophil engraftment at 42 days following transplantation and to assess the incidence of secondary graft failure at 180 days following transplantation of NiCord® Ten evaluable patients recruited for the study should be 12-65 years of age, up to a maximum of 15 treated patients.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Genoa, Italy, 16147
- Children Hospital Gaslini Scientific Institute
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Turin, Italy, 10043
- University of Turin
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Utrecht, Netherlands, 3503 AB
- University Medical Center Utrecht
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Singapore, Singapore, 169608
- Singapore General Hospital
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Singapore, Singapore, 119074
- National University Cancer Institute
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Barcelona, Spain, 08035
- University Hospital Vall d´Hebron
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Valencia, Spain, 46009
- Hospital Universitario La Fe
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University, Cardinal Bernardin Cancer Center
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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New York
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New York, New York, United States, 11040
- Steven and Alexandra Cohen Children's Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Tennessee
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Nashville, Tennessee, United States, 37240
- Vanderbilt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Applicable disease and eligible for myeloablative SCT
- Patients must have two partially HLA-matched CBUs
- Back-up stem cell source
- Adequate Karnofsky Performance score or Lansky Play-Performance scale
- Sufficient physiological reserves
- Signed written informed consent
Exclusion Criteria:
- HLA-matched donor able to donate
- Prior allogeneic HSCT
- Other active malignancy
- Active or uncontrolled infection
- Active/symptoms of central nervous system (CNS) disease
- Pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: NiCord®
NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engraftment
Time Frame: 42 days
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Assess the cumulative incidence of patients with NiCord®-derived neutrophil engraftment at 42 days following transplantation.
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42 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Leukemia, Lymphoid
- Leukemia, Myeloid
- Neoplasms
- Myelodysplastic Syndromes
- Hematologic Neoplasms
- Leukemia
- Leukemia, Myeloid, Acute
- Preleukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Other Study ID Numbers
- GC P#03.01.020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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