P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01854567 |
Recruitment Status :
Completed
First Posted : May 15, 2013
Last Update Posted : June 26, 2020
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Condition or disease | Intervention/treatment | Phase |
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Acute Myelogenous Leukemia Acute Lymphoblastic Leukemia Non-Hodgkin's Lymphoma Hodgkin's Disease | Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit Biological: Infusion of two unexpanded cord blood units. | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment |
Actual Study Start Date : | August 2013 |
Actual Primary Completion Date : | September 23, 2016 |
Actual Study Completion Date : | May 5, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Active
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
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Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit
Infusion of one MPC expanded cord unit and one unexpanded cord unit. |
Active Comparator: Control
Infusion of two unexpanded cord blood units.
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Biological: Infusion of two unexpanded cord blood units.
Umbilical Cord Blood. |
- Time to Neutrophil and Platelet Engraftment [ Time Frame: 100 days ]
- Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100 [ Time Frame: 100 days ]
- Percentage of patients with primary graft failure [ Time Frame: 100 days ]
- Incidence and severity of acute Graft Versus Host Disease [ Time Frame: 100 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Patient must have one of the following:
- Acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
- Acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
- Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant.
- Hodgkin's disease: High risk subjects with responsive disease after first relapse.
- Minimum Karnofsky Scale
- Subject must weigh at least 20 kg
- Up to 65 years of age
- Adequate major organ system function
Exclusion Criteria:
- Pregnancy and/or lactating
- Suitable, 6/6 HLA matched related sibling donor available
- Previous participation in a stem cell study within last 30 days

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): NCT01854567
United States, Florida | |
University of Miami Health System Sylvester Comprehensive Cancer Center | |
Miami, Florida, United States, 33136 | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
Weill Cornell-New York Presbyterian Hospital | |
New York, New York, United States, 10065 | |
Westchester Medical Center | |
Valhalla, New York, United States, 10595 | |
United States, Ohio | |
Case Western | |
Cleveland, Ohio, United States, 44106 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Texas Transplant Center at Methodist Healthcare System | |
San Antonio, Texas, United States, 78229 |
Study Director: | Donna Skerrett, MD, MS | Mesoblast, Ltd. | |
Principal Investigator: | Elizabeth J. Shpall, MD | M.D. Anderson Cancer Center |
Responsible Party: | Mesoblast, Ltd. |
ClinicalTrials.gov Identifier: | NCT01854567 |
Other Study ID Numbers: |
CB-AB006 2012-0166 ( Other Identifier: UT MDACC ) |
First Posted: | May 15, 2013 Key Record Dates |
Last Update Posted: | June 26, 2020 |
Last Verified: | June 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cord Blood Stem Cells MPC Mesoblast Expanded |
AML ALL NHL Leukemia Lymphoma |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Hematologic Neoplasms Leukemia, Myeloid, Acute Hodgkin Disease Lymphoma Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid Neoplasms by Site Hematologic Diseases |