Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01633229 · ClinicalTrials.gov registry record · Phase 1
Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01633229: Completed Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01633229 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01633229, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: * Bone marrow stromal cells (BMSC) from bone marrow biopsies can be used to treat disorders that cause inflammation and immune system diseases. BMSC have been used to treat graft versus host disease (GVHD), a complication that can develop after stem cell transplants. BMSC have also been used to treat other post-transplant complications, like marrow failure or tissue injury. * The National Institutes of Health (NIH) has developed a procedure for collecting and preserving BMSC from volunteer donors. These donors have passed tests to ensure that their cells are healthy enough to be used for treatment. Researchers want to use the collected cells to treat people with GVHD, marrow failure, or tissue injury following stem cell transplants. Objectives: \- To test the safety and effectiveness of NIH-collected BMSC to treat complications from stem cell transplants. Eligibility: * Individuals between 18 and 75 years of age who have complications from stem cell transplants. * Complications are acute GVHD, poor bone marrow function, or tissue or organ damage. Design: * Participants will be screened with a physical exam and medical history. They will also have imaging studies and blood tests. * Participants will provide blood, skin, and bone marrow samples before the BMSC treatment. Additional samples, including tissue samples, will be collected after the start of treatment. * Participants will have up to three BMSC infusions. There will be a week between each infusion. Participants will be monitored closely during each infusion. Any side effects will be treated. * Treatment will be monitored with frequent blood tests and physical exams. * After the end of the infusions, participants will have regular followup visits for up to 2 years.
Interventions
- PROCEDURE Bone Marrow Stromal Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-11-14 |
| Est. Completion | 2018-03-08 |
| Phase | Phase 1 |
What the finished NCT01633229 record still lists
NCT01633229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Bone Marrow Stromal Cell Infusion is the first listed.
NCT01633229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01633229 about?
NCT01633229 is a clinical study titled "Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications". Background: * Bone marrow stromal cells (BMSC) from bone marrow biopsies can be used to treat disorders that cause inflammation and immune system diseases. BMSC have been used to treat graft versus host disease (GVHD), a complication that can develop after stem cell transplants. BMSC have also been...
What is the current status of trial NCT01633229?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2011-11-14. Estimated completion is 2018-03-08.
What interventions are being tested in trial NCT01633229?
The interventions under investigation include: Bone Marrow Stromal Cell Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT01633229?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01633229's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI