Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01033552 · ClinicalTrials.gov registry record · Phase 1
Biochemical Correction of Severe EB by Allo HSCT and "Off-the-shelf" MSCs
A Phase 1 study of Epidermolysis Bullosa, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT01033552 is a Phase 1 study of Epidermolysis Bullosa that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 32 participants, above the 17-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (88% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01033552, a Phase 1 study of Epidermolysis Bullosa, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, single institution, phase II study in patients with epidermolysis bullosa (EB). The underlying hypothesis is that the infusion of bone marrow or umbilical cord blood from a healthy unaffected donor will correct the collagen, laminin, integrin, or plakin deficiency and reduce the skin fragility characteristic of severe forms of EB. A secondary hypothesis is that mesenchymal stem cells from a healthy donor will enhance the safety and efficacy of the allogeneic hematopoietic stem cell transplant as well as serve as a source of renewable cells for the treatment of focal areas of residual blistering.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Anti-thymocyte globulin
- DRUG Myeloablative Busulfan
- PROCEDURE Mesenchymal stem cell transplantation
Study Locations (1)
Minnesota
- University of Minnesota Masonic Cancer Center and Medical Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2010-01 |
| Est. Completion | 2021-08-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01033552
The ClinicalTrials.gov registry entry for NCT01033552 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 17-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (88% higher). The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Epidermolysis Bullosa appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01033552 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01033552 about?
NCT01033552 is a clinical study titled "Biochemical Correction of Severe EB by Allo HSCT and "Off-the-shelf" MSCs". This is an open-label, single institution, phase II study in patients with epidermolysis bullosa (EB). The underlying hypothesis is that the infusion of bone marrow or umbilical cord blood from a healthy unaffected donor will correct the collagen, laminin, integrin, or plakin deficiency and reduce t...
What is the current status of trial NCT01033552?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2010-01. Estimated completion is 2021-08-12.
What conditions does trial NCT01033552 study?
This clinical trial studies the following conditions: Epidermolysis Bullosa.
What interventions are being tested in trial NCT01033552?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Anti-thymocyte globulin (DRUG), Myeloablative Busulfan (DRUG), Mesenchymal stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT01033552?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01033552 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Epidermolysis Bullosa
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.
-
Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
RECRUITING · Phase 1
-
Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa
COMPLETED · Phase 1
-
A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients
ACTIVE NOT RECRUITING · Phase 3
-
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Epidermolysis Bullosa (Phase III)
ACTIVE NOT RECRUITING · Phase 3
-
Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
COMPLETED · Early Phase 1
-
Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa
COMPLETED · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.