PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (141 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-08-01, after 2019-11-12 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2023-08-01. 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: chronicdiseasepresencewomendiabetes
Phrases that lowered it: screening visitto screeningskinopen labelprior to -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 9.1% (raises risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 117 (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
-
Sponsor's past trials: 408 (lowers risk) · Sponsor's track record
-
Number of arms: 3 (lowers risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Disease area, dermatology: Yes (raises risk) · Disease area
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 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 408 (typical: 32)
- Sponsor's past termination rate
- 9.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 117 (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, dermatology, endocrine
- 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
- Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients. NCT05595681 · started 2022 · scored riskier than 34% of active trials terminated
- Study to Evaluate the Safety and Efficacy of CHAM* for the Treatment of Diabetic Foot Ulcers NCT02571738 · started 2015 · scored riskier than 25% of active trials terminated
- Safety of ALLO-ASC-DFU in the Patients With Diabetic Foot Ulcers NCT02394886 · started 2014 · scored riskier than 44% of active trials completed
- Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use NCT01840085 · started 2015 · scored riskier than 86% of active trials terminated
- Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells to Non-healing Diabetic Foot Wounds NCT03509870 · started 2018 · scored riskier than 36% 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.