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| Name | Class |
|---|---|
| Gamida Cell ltd | INDUSTRY |
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While cord blood transplants have been performed safely in elderly patients, many still relapse. The investigators propose to intensify the preparative regimen for this patient group in an attempt to decrease relapses, and combine this with an ex vivo expanded Umbilical Cord Blood (UCB) unit.
Allogeneic stem cell transplantation is a life saving procedure in selected high-risk or recurrent hematologic malignancies and marrow failure syndromes. However its wide application is limited by availability of suitably HLA matched adult donors. Umbilical Cord Blood (UCB) has been increasingly used as an alternative hematopoietic stem cell source for these patients. To date, over 10,000 UCB transplants have been performed in both children32-38 and adults.35,39-44 Its advantages include easier procurement, decreased risk to donors, reduced risk of transmitting infections, the immediate availability of cryopreserved units, and acceptable HLA mismatches. The transplantation of UCB allows a greater degree of HLA mismatching without an unacceptably high incidence of graft versus host disease (GVHD). Adult patients receiving myeloablative cord blood transplants have a 90% chance of engraftment, but carry a 50% rate of transplant related mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unmanipulated arm | No Intervention | Participants that do not meet criteria for StemEx®, will be registered into the unmanipulated UCB arm and receive the standard conditioning regimen. | |
| Stemx Arm | Experimental | StemEx is a stem/progenitor cell-based product of ex-vivo expanded allogeneic UCB, which is administered to the subject in combination with the non-manipulated portion of the same cord blood unit (CBU). The CBU must be cryopreserved in two portions of which the larger (or equal) CBU portion contains at least 1.5 x 107 total nucleated cells (TNC)/Kg. This portion remains unmanipulated and is transplanted on Day 0. StemEx is derived from the smaller (or equal) CBU portion, which is expanded ex vivo for 21 days starting pre-transplant in the presence of cytokines TPO, IL-6, Flt-3L and SCF at a concentration of 50ng/ml and 5μM tetraethylenepentamine (TEPA) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| StemEx | Biological | For patients allocated to StemEx® arm:
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of StemEx | The primary endpoint is to demonstrate the efficacy of StemEx® vs. unmanipulated UCB transplantation in the elderly population (>55years of age) following RIC regimen by demonstrating engraftment with full donor chimerism (>98%) by Day 100 of more than 60% of the patients who received transplants expanded by the StemEx method. | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to engraftment | The day of neutrophil engraftment is defined as the first day of 3 consecutive days of an ANC greater than 500/microliter. The platelet recovery is the first of 3 consecutive measurements tested on different days of a platelet count greater than or equal to 20,000 without requiring platelet transfusions in the previous 7 days. Patients will be monitored for donor cell engraftment as evidenced by neutrophil recovery and donor chimerism in the marrow and/or peripheral blood at serial time points post transplant. |
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Inclusion Criteria:
Ages 55-73
Patients will have one of the following malignancies:
Patients with adequate organ function and performance status criteria
Subject must have at least one or the following back-up stem cell sources in case of engraftment failure:
Evaluation by social service/psychologist
Subject signs the written informed consent after being aware of the nature of the subject's disease and willingly consents to the treatment program after being informed of alternative treatments, potential risks, benefits and discomforts.
Ability to understand and agree to compliance with strict evaluation, isolation,and medication schedules
Designated primary care giver.
Dental evaluation/treatment completed.
ENT evaluation/treatment completed.
All patient who survive to day 90 are eligible for measurement of T and B cell function and lymphocyte subset numbers to determine immune reconstitution post UCB transplantation with or without StemEx®
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Stiff, MD | Loyola Universtiy Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 42 days |