Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01670981 · ClinicalTrials.gov registry record · Phase 2
An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)
A Phase 2 study, sponsored by Vericel Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
NCT01670981: Completed Phase 2 study, sponsored by Vericel Corporation.
NCT01670981 is a Phase 2 study that has completed, run by Vericel Corporation. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01670981, a Phase 2 study, has completed, sponsored by Vericel Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
Study Summary
This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit.
Primary Outcome
The primary endpoint will assess the efficacy of ixmyelocel-T compared to placebo (vehicle control) on the average number of events per patient over 12 months post-treatment in each treatment arm (total number events in each arm/total number of patients in each arm). The events include: all-cause deaths, cardiovascular hospitalizations, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure. The clinical events used in this endpoint will be adjudicated
Interventions
- OTHER Placebo
- BIOLOGICAL ixmyelocel-T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2013-02-20 |
| Est. Completion | 2018-03-07 |
| Phase | Phase 2 |
What the finished NCT01670981 record still lists
NCT01670981 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01670981 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01670981 about?
NCT01670981 is a clinical study titled "An Efficacy, Safety and Tolerability Study of Ixmyelocel-T Administered Via Transendocardial Catheter-based Injections to Subjects With Heart Failure Due to Ischemic Dilated Cardiomyopathy (IDCM)". This study is designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo (vehicle control) when administered via transendocardial catheter-based injections to patients with end stage heart failure due to IDCM, who have no reasonable revascularization options (either...
What is the current status of trial NCT01670981?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2013-02-20. Estimated completion is 2018-03-07.
What interventions are being tested in trial NCT01670981?
The interventions under investigation include: Placebo (OTHER), ixmyelocel-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT01670981?
This trial is sponsored by Vericel Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01670981's enrollment target sits among peer trials
114 627th of 2000 higher than 1,370 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
- NCT04522791 · 114 participants · Phase 2
Breathing, Relaxation, Attention Training, & Health in Older Adults (BREATHE)
- NCT04875052 · 114 participants · NA
Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury
- NCT05100342 · 114 participants
Prospective Validation of a Points Score System Predicting 30-day Survival
- NCT05224089 · 114 participants · Phase 4
Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy
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