Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:12 - 65
Updated:1/5/2019
Start Date:April 2013
End Date:June 2018

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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

A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit
(CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in
Patients with Hematological Malignancies.

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.

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
We found this trial at
9
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Richard Maziarz, MD
Phone: 503-494-4606
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Navneet Majhail, MD
Phone: 216-444-2199
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-668-1045
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Genoa, 16147
Principal Investigator: Francesco Frassoni, MD
Phone: +39 (010) 563669
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Genoa,
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Maywood, IL
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Nashville, Tennessee 37212
Principal Investigator: Madan Jagasia, MD
Phone: 615-936-8422
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Nashville, TN
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New York, New York 11040
Principal Investigator: Joel Brochstein, MD
Phone: 718-470-3460
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New York, NY
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