Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01810588 · OUTCOME

Number of Subjects Who Achieved Engraftment With De-Escalating Umbilical Cord Total Nucleated Cell (TNC) Dose

Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation · Source last updated 2026-08-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
100 days

What was measured

We aim to identify the lowest threshold of umbilical cord total nucleated cell (TNC) dose that can be utilized assure durable umbilical cord blood engraftment in the haplo-cord transplants. The threshold will be defined as the lowest dose which assures cord blood engraftment occurs in at least 80% of subjects.

Analysis population: A subset of participants were assessed to analyze the lowest threshold of umbilical cord total nucleated cell (TNC) dose. Once the lowest threshold was established, the remaining participants on study were treated based on that threshold.

Groups in this outcome

All Patients

Haplo-cord transplantation: For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Patients60

Reported measurements

Participants Achieving Engraftment with Minimum TNC of 2 x 10^5/kg

Analysis denominator · Participants

GroupSource count
All Patients15
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients15Not reportedNot reportedNot reportedNot reported
Participants Achieving Engraftment with Minimum TNC of 1 x 10^5/kg in umbilical cord blood unit

Analysis denominator · Participants

GroupSource count
All Patients20
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients18Not reportedNot reportedNot reportedNot reported
Participants Achieving Engraftment with Minimum TNC of 0.5 x 10^5/kg

Analysis denominator · Participants

GroupSource count
All Patients25
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Participants Achieving Engraftment with Minimum TNC of 2 x 10^5/kg
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Participants Achieving Engraftment with Minimum TNC of 1 x 10^5/kg in umbilical cord blood unit
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    Participants Achieving Engraftment with Minimum TNC of 0.5 x 10^5/kg
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    units
    Participants
description
We aim to identify the lowest threshold of umbilical cord total nucleated cell (TNC) dose that can be utilized assure durable umbilical cord blood engraftment in the haplo-cord transplants. The threshold will be defined as the lowest dose which assures cord blood engraftment occurs in at least 80% of subjects.
groups
  1. description
    Haplo-cord transplantation: For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor).
    id
    OG000
    title
    All Patients
param Type
NUMBER
population Description
A subset of participants were assessed to analyze the lowest threshold of umbilical cord total nucleated cell (TNC) dose. Once the lowest threshold was established, the remaining participants on study were treated based on that threshold.
reporting Status
POSTED
time Frame
100 days
title
Number of Subjects Who Achieved Engraftment With De-Escalating Umbilical Cord Total Nucleated Cell (TNC) Dose
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice