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COMPLETED Phase 2

Stem Cell Transplant for Hemoglobinopathy

NCT00176852 · View on ClinicalTrials.gov ↗

Study Summary

This study tests the clinical outcomes of one of two preparative regimens (determined by available donor source) in patients with non-malignant hemoglobinopathies. The researchers hypothesize that these regimens will have a positive effect on post transplant engraftment and the incidence of graft-versus-host-disease. Regimen A2 has replaced Regimen A in this study. Two patients were treated on Regimen A but did not have evidence of initial engraftment thus triggering the stopping rule for that arm of this study.

Interventions

  • RADIATION Total Body Irradiation
  • PROCEDURE Stem cell infusion
  • DRUG Busulfan, Fludarabine, ATG, TLI
  • DRUG Busulfan, Cyclophosphamide, ATG, GCSF
  • DRUG Campath, Fludarabine, Cyclophosphamide

Study Locations (1)

Minnesota

  • Masonic Cancer Center, University of Minnesota — Minneapolis

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2002-06
Est. Completion 2020-01
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00176852

The ClinicalTrials.gov registry entry for NCT00176852 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 154 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 5 interventions — of which Total Body Irradiation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00176852 reports 1 study location spanning 1 distinct geographic area — top geographies include Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00176852 about?

NCT00176852 is a clinical study titled "Stem Cell Transplant for Hemoglobinopathy". This study tests the clinical outcomes of one of two preparative regimens (determined by available donor source) in patients with non-malignant hemoglobinopathies. The researchers hypothesize that these regimens will have a positive effect on post transplant engraftment and the incidence of graft-ve...

What is the current status of trial NCT00176852?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2002-06. Estimated completion is 2020-01.

What conditions does trial NCT00176852 study?

This clinical trial studies the following conditions: Sickle Cell Disease, Thalassemia, Diamond-Blackfan Anemia, Severe Congenital Neutropenia, Shwachman-Diamond Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00176852?

The interventions under investigation include: Total Body Irradiation (RADIATION), Stem cell infusion (PROCEDURE), Busulfan, Fludarabine, ATG, TLI (DRUG), Busulfan, Cyclophosphamide, ATG, GCSF (DRUG), Campath, Fludarabine, Cyclophosphamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00176852?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 154 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00176852 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial