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NCT02181478 · ClinicalTrials.gov registry record · Early Phase 1

Intra-Osseous Co-Transplant of UCB and hMSC

A Early Phase 1 study, sponsored by Case Comprehensive Cancer Center.

Completed
Registry status
Early Phase 1
Development phase
6
Enrollment target

NCT02181478: Completed Early Phase 1 study, sponsored by Case Comprehensive Cancer Center.

NCT02181478 is a Early Phase 1 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02181478, a Early Phase 1 study, has completed, sponsored by Case Comprehensive Cancer Center.

COMPLETED
Registry status
Early Phase 1
Development phase
6 participants
Enrollment target

Study Summary

This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal cell co-transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood and mesenchymal stromal cells into the bone (intra-osseous) helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil at the time of transplant may stop this from happening.

Primary Outcome

Primary graft failure is defined by \<10% BM cellularity in bone marrow biopsies. Failure in more than 30% of patients will indicate unfeasibility of treatment

Interventions

  • DRUG cyclophosphamide
  • DRUG fludarabine phosphate
  • DRUG cyclosporine
  • RADIATION total-body irradiation
  • DRUG mycophenolate mofetil

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2015-07-22
Est. Completion 2020-02-07
Phase Early Phase 1
Case Comprehensive Cancer Center

407 total trials

What the finished NCT02181478 record still lists

NCT02181478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.

NCT02181478 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02181478 about?

NCT02181478 is a clinical study titled "Intra-Osseous Co-Transplant of UCB and hMSC". This clinical trial studies intra-osseous donor umbilical cord blood and mesenchymal stromal cell co-transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy and total-body irradiation before a co-transplant of donor umbilical cord blood and mesenchymal stromal...

What is the current status of trial NCT02181478?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2015-07-22. Estimated completion is 2020-02-07.

What interventions are being tested in trial NCT02181478?

The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), cyclosporine (DRUG), total-body irradiation (RADIATION), mycophenolate mofetil (DRUG).

Who is sponsoring clinical trial NCT02181478?

This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT02181478's enrollment target sits among peer trials

6 1845th of 2000 higher than 114 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02181478, the US trial registry maintained by the National Library of Medicine. NCT02181478 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.