P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01854567

Enrollment

Registered

2013-05-15

Start date

2013-08-31

Completion date

2017-05-05

Last updated

2020-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Hodgkin's Disease, Non-Hodgkin's Lymphoma

Keywords

Cord Blood, Stem Cells, MPC, Mesoblast, Expanded, AML, ALL, NHL, Leukemia, Lymphoma

Brief summary

The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.

Interventions

BIOLOGICALInfusion of one MPC expanded cord unit and one unexpanded cord unit

Infusion of one MPC expanded cord unit and one unexpanded cord unit.

BIOLOGICALInfusion of two unexpanded cord blood units.

Umbilical Cord Blood.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Time to Neutrophil and Platelet Engraftment	100 days

Secondary

Measure	Time frame
Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100	100 days
Percentage of patients with primary graft failure	100 days

Other

Measure	Time frame
Incidence and severity of acute Graft Versus Host Disease	100 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026