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NCT01586455 · ClinicalTrials.gov registry record · Phase 1

Human Placental-Derived Stem Cell Transplantation

A Phase 1 study of Batten Disease and Mucopolysaccharidosis VI, sponsored by New York Medical College.

Completed
Registry status
Phase 1
Development phase
43
Enrollment target
3
Study locations

NCT01586455: Completed Phase 1 study of Batten Disease and Mucopolysaccharidosis VI, sponsored by New York Medical College.

NCT01586455 is a Phase 1 study of Batten Disease and Mucopolysaccharidosis VI that has completed, run by New York Medical College. The registered enrollment target is 43 participants, below the 2,826-participant average among 11 other Batten Disease trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01586455, a Phase 1 study of Batten Disease and Mucopolysaccharidosis VI, has completed, sponsored by New York Medical College.

COMPLETED
Registry status
Phase 1
Development phase
43 participants
Enrollment target
3
Study locations

Study Summary

The purpose of this clinical trial is to investigate the safety of human placental-derived stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in patients with various malignant or nonmalignant disorders who require a stem cell transplant. Patients will get either full dose (high-intensity) or lower dose (low intensity) chemo- and immunotherapy followed by a stem cell transplantation with UCB and HPDSC.

Primary Outcome

to evaluate the safety of human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells in patients with malignant and non-malignant diseases.

Conditions Studied

Batten Disease Mucopolysaccharidosis VI Adrenoleukodystrophy Mucopolysaccharidosis I Wolman Disease Gaucher's Disease Fucosidosis Metachromatic Leukodystrophy Niemann-Pick Disease Krabbe's Disease

Interventions

  • DRUG Human Placental Derived Stem Cell

Study Locations (3)

Colorado

  • Children's Hospital Colorado - Denver

New York

  • New York Medical College - Valhalla

Utah

  • University of Utah - Salt Lake City

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2013-04
Est. Completion 2022-09
Phase Phase 1
New York Medical College

47 total trials

What the finished NCT01586455 record still lists

NCT01586455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 2,826-participant average among 11 other Batten Disease trials with a reported enrollment target (98% lower).

The record links to 10 conditions, with Batten Disease appearing as the primary indexed condition, and to 1 intervention - of which Human Placental Derived Stem Cell is the first listed.

NCT01586455 reports a single indexed study location in Colorado, New York, Utah.

Frequently Asked Questions

What is clinical trial NCT01586455 about?

NCT01586455 is a clinical study titled "Human Placental-Derived Stem Cell Transplantation". The purpose of this clinical trial is to investigate the safety of human placental-derived stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in patients with various malignant or nonmalignant disorders who require a stem cell transplant. Patients will get either full...

What is the current status of trial NCT01586455?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2013-04. Estimated completion is 2022-09.

What conditions does trial NCT01586455 study?

This clinical trial studies the following conditions: Batten Disease, Mucopolysaccharidosis VI, Adrenoleukodystrophy, Mucopolysaccharidosis I, Wolman Disease.

What interventions are being tested in trial NCT01586455?

The interventions under investigation include: Human Placental Derived Stem Cell (DRUG).

Who is sponsoring clinical trial NCT01586455?

This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01586455 being conducted?

This trial has 3 study locations across Colorado, New York, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01586455's enrollment target sits among peer trials

43 7th of 11 higher than 5 of 11 other Batten Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Batten Disease 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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Related registry views

Source: ClinicalTrials.gov NCT01586455, the US trial registry maintained by the National Library of Medicine. NCT01586455 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.