Phase 2
N=120
Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)
Left Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00684021 ↗Enrolled (actual)
120
Serious AEs
30.0%
Results posted
Apr 2013
Primary outcome: Primary: Global Left Ventricular Function — 3.5; 4.4; 2.8; 1.7 percentage of ejection fraction — p=0.959
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Adult stem cells (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Left Ventricular Function |
3.5; 4.4; 2.8; 1.7 | 0.959 |
| PRIMARY Regional Left Ventricular Function (Infarct Zone Wall Motion) |
2.1; 2.4; 1.2; 2.8 | 0.409 |
| PRIMARY Regional Left Ventricular Function (Border Zone Wall Motion) |
3.5; 4.3; 4.2; 4.4 | 0.777 |
| SECONDARY Clincal and Safety Outcomes |
10; 9; 6; 1 | 0.93 |
| SECONDARY Left Ventricular Mass |
-20.4; -13.2; -16.3; -20.7 | 0.585 |
| SECONDARY End Diastolic Volume Index |
11.4; 11.7; 13.3; 9.7 | 0.831 |
| SECONDARY End Systolic Volume Index |
4.1; 4.1; 6.2; 4.6 | 0.817 |
| SECONDARY Infarct Volume |
-9.7; -7.7; -13.6; -5.3 | 0.272 |
Summary
Heart attacks are a leading cause of death for both men and women in the United States. A heart attack occurs when blood flow to the heart is restricted, commonly due to a blood clot that has formed in one of the coronary arteries. If the clot becomes large enough, blood flow to the heart can be blocked almost completely and the heart muscle in that area can suffer permanent injury or death. Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function after a heart attack. This study will evaluate the safety and effectiveness of using adult stem cells for improving heart function in people who have had a recent heart attack and a PCI.
Eligibility Criteria
Inclusion criteria
- Patients at least 21 years of age
- Patients with first acute MI with successful primary percutaneous coronary intervention (PCI) in an artery at least 2.5 mm in diameter within 24 hours of onset of symptoms.
- No contraindications to undergoing cell therapy procedure within three to seven days following AMI and PCI.
- Hemodynamic stability as defined as no requirement for IABP, inotropic or blood pressure supporting medications.
- Ejection fraction following reperfusion with PCI 70% luminal obstruction in the non-infarct related vessel (Additional PCI of non-culprit vessels may be performed prior to enrollment).
- History of any malignancy within the past five years excluding non-melanoma skin cancer or cervical cancer in-situ.
- History of chronic anemia (hemoglobin (Hb) 500k).
- History of thrombocytopenia in the absence of recent evidence that platelet counts are normal
- Known history of elevated INR (PT) or PTT.
- Life expectancy less than one year.
- History of untreated alcohol or drug abuse.
- Currently enrolled in another investigational drug or device trial
- Previous CABG.
- Previous MI resulting in LV dysfunction (LVEF 3+ mitral regurgitation).
- Pregnancy or breast feeding
- Subjects with a known history of HIV, or has active hepatitis B,active hepatitis C, or active TB
- Patients with active inflammatory or autoimmune disease on chronic immuno-suppressive therapy.
- Contraindications to cMRI.
- Previous radiation to the pelvis with white blood cell count (WBC) and platelet counts below hospital specific normal values.
- Women child bearing potential not willing to practice an active form of birth control.
- Chronic liver disease that might interfere with survival or treatment with cell therapy.
- Chronic renal insufficiency as defined by a creatinine ≥ 2.0 mg/dL or requires chronic dialysis.
Data sourced from ClinicalTrials.gov (NCT00684021). 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.