Biochemical Correction of Severe EB by Allo HSCT and Off-the-shelf MSCs
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 20% of the time (1,813 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 2021-08-12, after 2010-01-31 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 2021-08-12. 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: donorcellmarrowcellshla
Phrases that lowered it: healthyefficacysinglerangehiv -
Sponsor's past termination rate: 58.3% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 29.1% (raises risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: not given (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 95.7% (raises risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Blinding: none (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
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Collaborators: 0 (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
- 1/2 (typical: 2)
- Number of arms
- 4 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 25 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 36 (typical: 32)
- Sponsor's past termination rate
- 58.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 18 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 16508 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4051 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- dermatology
- Drugs matched to FDA substances
- busulfan, cyclophosphamide, fludarabine
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
- MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs NCT02582775 · started 2016 · scored riskier than 94% of active trials completed
- Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) NCT04227106 · started 2020 · scored riskier than 34% of active trials completed
- Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa NCT01263379 · started 2010 · scored riskier than 55% of active trials completed
- Open-label, Pivotal Clinical Trial to Confirm Efficacy and Safety of Autologous Grafts Containing Stem Cells Genetically Modified for Epidermis Restoration in Patients With Junctional Epidermolysis Bullosa NCT05111600 · started 2022 · scored riskier than 47% of active trials terminated
- Clinical Trial to Assess Safety and Efficacy of Autologous Cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified in Patients With RDEB. NCT02984085 · started 2017 · scored riskier than 29% of active trials terminated
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.