Infusion Intracoronary of Mononuclear Autologous Adult no Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (446 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2020-04-21, after 2014-01-06 start.
Reason given by the sponsor: “efficacy”
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-04-21. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: heartmarrowleftcellsbone
Phrases that lowered it: aminotransferaseclinicalthe efficacytypewomen -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
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Keywords listed: 0 (raises risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
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Sponsor's past trials: 1 (raises risk) · Sponsor's track record
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- none matched
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM) NCT00765518 · started 2008 · scored riskier than 97% of active trials completed
- Intracoronary Transplantation of Bone Marrow Derived Mononuclear Cells in Pediatric Cardiomyopathy NCT02256501 · started 2013 · scored riskier than 46% of active trials completed
- Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy NCT01302171 · started 2010 · scored riskier than 63% of active trials completed
- Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study) NCT00824005 · started 2009 · scored riskier than 97% of active trials completed
- Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC]) Treatment in Patients With Heart Failure Due to Dilated Cardiomyopathy NCT01020968 · started 2009 · scored riskier than 99% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.