Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy

NCT01302171 on ClinicalTrials.gov Phase 2 Barts & The London NHS Trust (academic or other) Started 2010-08-31 Completed

Riskier than 63% of active trials

Model scores of the 29,894 trials active now.

Model score 19% for any early termination, 8% 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

Completed on 2013-07-31, after 2010-08-31 start.

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 2013-07-31. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: ventricularcellsleftheartmarrow
Phrases that lowered it: evaluate theto evaluateabusetrial tovirus
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Drug's FAERS reports with a death: 36.0% (raises risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Collaborators: 2 (lowers risk) · Design
Phase: 2 (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Responsible party: principal investigator (lowers risk) · Design
Maximum age: 80 (lowers risk) · Who can join
Trials the sponsor started in the prior 2 years: 9 (raises risk) · Sponsor's track record
Sponsor's past trials: 6 (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 95.3% (raises risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Number of arms: 2 (raises risk) · Design

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: principal investigator (typical: sponsor)
Collaborators: 2 (typical: 0)
Keywords listed: 9 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 80 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 6 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 9 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 317 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 116 (typical: 412.5)
Drug's FAERS reports marked serious: 95.3% (typical: 85.6%)
Drug's FAERS reports with a death: 36.0% (typical: 15.9%)

Disease area and drugs

Disease areas: cardiovascular
Drugs matched to FDA substances: lenograstim

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

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. NCT02033278 · started 2014 · scored riskier than 79% of active trials terminated
C-Cure Clinical Trial NCT00810238 · started 2008 · scored riskier than 82% of active trials completed
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
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
Bone Marrow Derived Mesenchymal Stem Cells in Improving Heart Function in Patients With Heart Failure Caused by Anthracyclines NCT02408432 · started 2016 · scored riskier than 97% 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.