Phase 2
Completed N=30
The TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis STudy (The TRIDENT Study)
Chronic Ischemic Left Ventricular Dysfunction · Myocardial Infarction
Source: ClinicalTrials.gov NCT02013674 ↗
Enrolled (actual)
30
Serious AEs
20.0%
Results posted
Feb 2020
Primary outcomePrimary: Number of Participants With Treatment-emergent Serious Adverse Events (SAE). — 0; 0 Participants
Summary
Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI scheduled to undergo cardiac catheterization will be enrolled in the study. This is a phase II study intended to gain additional safety and efficacy assessments among two dose levels previously studied in a phase I setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Serious Adverse Events (SAE). |
0; 0 | — |
| SECONDARY Infarct Scar Size (ISS) |
9.9; 9.7; 6.8; 5.6 | — |
| SECONDARY Number of Participant With Reported Tissue Perfusion |
0; 0; 0; 0 | — |
| SECONDARY Peak Oxygen Consumption (VO2) |
15.8; 16.7; 15.0; 16.5; 14.4; 16.3 | — |
| SECONDARY Six-minute Walk Test. |
398.7; 434.9; 396.1; 433.5; 416.4; 453.6 | — |
| SECONDARY Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level. |
2; 4; 10; 9; 3; 2 | — |
| SECONDARY Number of Incidents of Major Adverse Cardiac Events (MACE). |
0; 0; 3; 2; 3; 2 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Event (AE) |
8; 10; 10; 13 | — |
| SECONDARY Minnesota Living With Heart Failure (MLHF) Questionnaire Scores |
29.0; 35.0; 22.0; 20.0; 30.0; 21.5 | — |
| SECONDARY Echocardiographic-derived Measures of Left Ventricular Function |
5.8; 6.3; 6.1; 6.2 | — |
| SECONDARY Difference Between Regional Left Ventricular Function (at the Site of Allogeneic Cell Injections) |
— | — |
| SECONDARY Difference Between the Regional Left Ventricular Wall Thickening |
— | — |
| SECONDARY Difference Between Left Ventricular End Diastolic Wall Thickness |
— | — |
| SECONDARY Difference Between the Left Ventricular Ejection Fraction (LVEF) |
-0.27; 3.00 | — |
| SECONDARY Difference in LVEF |
— | — |
| SECONDARY Difference in Left Ventricular Volume |
7.65; 3.70 | — |
| SECONDARY Difference in Left Ventricular Regional Myocardial Perfusion |
— | — |
| SECONDARY Number of Participants With Abnormal Electrocardiogram (ECG) Reads. |
0; 1; 15; 14; 0; 0 | — |
| SECONDARY Number of Clinically Significant of Abnormal Lab Values. |
— | — |
| SECONDARY Serial Troponin I |
0.01; 0.01; 0.06; 0.05 | — |
| SECONDARY Number of Participants With Abnormal ECHO Reading |
1; 2; 6; 6; 0; 0 | — |
| SECONDARY Creatinine Kinase Muscle/Brain (CK-MB) |
3.25; 2.45; 4.20; 4.40 | — |
Eligibility Criteria
Inclusion Criteria
- In order to participate in this study, a patient MUST:
- Be ≥ 21 and 550 ms on screening ECG
- Automatic Implantable Cardioverter Defibrillator (AICD) firing in the past 60 days prior to enrollment.
- Have a hematologic abnormality as evidenced by hematocrit 1.3) not due to a reversible cause (i.e., Coumadin). Patients on Coumadin will be withdrawn 5 days before the procedure and confirmed to have an INR < 1.3. Patients who cannot be withdrawn from Coumadin will be excluded from enrollment
- Have known allergies to penicillin or streptomycin.
- Hypersensitivity to Dimethyl Sulfoxide (DMSO).
- Be an organ transplant recipient.
- Have a history of organ or cell transplant rejection
- Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma.
- Have a non-cardiac condition that limits lifespan to < 1 year.
- Have a history of drug or alcohol abuse within the past 24 months.
- Be on chronic therapy with immunosuppressant medication, such as corticosteroids or TNFα antagonists.
- Be serum positive for HIV, hepatitis BsAg or viremic hepatitis C.
- Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to injection.
Data sourced from ClinicalTrials.gov (NCT02013674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.