Phase 2
N=87
Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)
Left Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00684060 ↗Enrolled (actual)
87
Serious AEs
25.3%
Results posted
May 2012
Primary outcome: Primary: Global Left Ventricular Function — 0.5; 3.6 percentage of ejection fraction — p=<0.05
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
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Left Ventricular Function |
0.5; 3.6 | <0.05 sig |
| PRIMARY Regional Left Ventricular Function (Infarct Zone Wall Motion) |
0.3; 1.0 | <0.05 sig |
| PRIMARY Regional Left Ventricular Function (Border Zone Wall Motion) |
0.5; 3.2 | <0.05 sig |
| SECONDARY Combined Endpoint |
3; 4 | <0.05 sig |
| SECONDARY Left Ventricular Mass |
-12.0; -10.8 | <0.05 sig |
| SECONDARY End Diastolic Volume Index |
3.4; 2.7 | <0.05 sig |
| SECONDARY End Systolic Volume Index |
0.2; -2.3 | <0.05 sig |
| SECONDARY Infarct Volume |
-3.5; -2.0 | <0.05 sig |
Summary
More than 1 million Americans suffer heart attacks each year. Although current treatments are able to stabilize the condition of the heart, none is able to restore heart function as it was prior to the heart attack. Adult stem cells, which are immature cells that can become many different types of cells, may offer a potential means of reversing or preventing permanent damage caused by a heart attack. Recent studies have shown promise in using adult stem cells from bone marrow to reverse damage to the heart muscle caused by a heart attack, but more research is needed to assess the safety and effectiveness of stem cell use and to discover the best time to administer treatment. This study will evaluate the safety and effectiveness of using adult stem cell infusions 2 to 3 weeks after a heart attack for improving heart function in people who have had a recent heart attack and a common procedure called a percutaneous coronary intervention (PCI).
Eligibility Criteria
Inclusion criteria
- Patients at least 21 years of age.
- Patients with first acute MI and subsequent successful primary percutaneous coronary intervention (PCI) in an artery at least 2.5 mm in diameter occurring two to three weeks before recruitment.
- No contraindications to undergoing cell therapy procedure within two to three weeks 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 tuberculosis (TB)
- Patients with active inflammatory or autoimmune disease on chronic immunosuppressive 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 (NCT00684060). 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.