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NCT01851343 · ClinicalTrials.gov registry record · Phase 1
Bone Marrow Stromal Cells for Inflammatory Bowel Diseases
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01851343 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 8 participants.
The verdict
NCT01851343, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Background: \- Bone marrow stromal cells (BMSCs) are cells that can develop into other tissue types, including bone, cartilage, marrow, and blood cells. However, BMSCs are not stem cells there is no evidence that after infusion into another person that BMSCs change into any other cells. Research suggests that BMSCs can travel to different parts of the body and work with immune cells to reduce inflammation and help repair damaged tissues. BMSC infusions have been used in tests to treat moderate to severe inflammatory bowel disease, like Crohn's disease (CD) or ulcerative colitis (UC). These tests have shown some good results, but more research is needed to study their safety and effectiveness. Researchers want to see how well BMSC infusions work to treat CD and UC. The BMSCs will be collected from volunteer donors. Objectives: \- To look at the safety and effectiveness of BMSC infusions for moderate to severe CD and UC. Eligibility: \- Individuals between 18 and 65 years old with moderate or severe inflammatory bowel disease (CD or UC) that has not responded to standard treatment. Design: * Participants will have two screening visits. The first will be 15 to 30 days before the first BMSC infusion. The second will be within 14 days of the first BMSC infusion. * At the first screening visit, participants will have a physical exam and medical history. They will provide blood, urine, and stool samples. They will also give information about their symptoms and quality of life. * At the second screening visit, participants will have their vital signs (like blood pressure and heart rate) measured. They will also provide blood samples, and have a colonoscopy with biopsies. * During treatment, participants will have one BMSC infusion per week for 4 weeks. Blood and urine samples will be collected at each treatment visit. * One week after the last infusion, participants will have a study visit. The tests from the first and second screening visits will be repeated. * Ther
Interventions
- OTHER Bone Marrow Stromal Cell (BMSC) Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-01-27 |
| Est. Completion | 2017-07-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01851343
The ClinicalTrials.gov registry entry for NCT01851343 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bone Marrow Stromal Cell (BMSC) Infusion is the first listed.
NCT01851343 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01851343 about?
NCT01851343 is a clinical study titled "Bone Marrow Stromal Cells for Inflammatory Bowel Diseases". Background: \- Bone marrow stromal cells (BMSCs) are cells that can develop into other tissue types, including bone, cartilage, marrow, and blood cells. However, BMSCs are not stem cells there is no evidence that after infusion into another person that BMSCs change into any other cells. Research su...
What is the current status of trial NCT01851343?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-01-27. Estimated completion is 2017-07-12.
What interventions are being tested in trial NCT01851343?
The interventions under investigation include: Bone Marrow Stromal Cell (BMSC) Infusion (OTHER).
Who is sponsoring clinical trial NCT01851343?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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