One Year Follow-Up Results From Preserve-Ami: A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Intracoronary Infusion of Autologous Cd34+ Cells in Patients With Left Ventricular Dysfunction Post Stemi

Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study)

“…Yet other subanalyses of clinical trials that tested different cell doses failed to determine a linear pattern of dose-response. 7,8 These inconsistencies among the results from different trials examining optimal dosing reflect the complexity of dosing in cell-based therapies. As with pharmacological agents, establishing an efficacious dose and cell concentration is critical to successful therapeutic outcomes.…”

Granulocyte-colony stimulating factor for large anterior ST-elevation myocardial infarction: Rationale and design of the prospective randomized phase III STEM-AMI OUTCOME trial

“…These findings are in accordance with previous reports on the positive correlation between spontaneous mobilization of circulating progenitors after STEMI and parameters of longterm LV recovery, 36 or with a dose-dependent effect of intracoronary injected CD34 + cells on LV function. 37 We showed that the number of CD34 + cells mobilized by G-CSF in the systemic circulation is more than 50 cells/μL of blood above control 19 : it can be then estimated that approximately 1.44 × 10 10 progenitors circulate in the "culprit" artery in 6 days of G-CSF treatment on top of spontaneous mobilization. 38 Conversely, an average of 7.34 × 10 6 CD34 + cells was injected intracoronary in the TOPCARE-AMI trial.…”

The (Translational) Road Less Traveled

“…2 To date, there have been at least 700 patients enrolled in clinical trials of CD34 + cell therapy for ischemic tissue repair. The editors of Nature Biotechnology seem to equate the failure of a single, phase 2 clinical trial to show a statistically significant improvement in a clinically ambiguous end point (SPECT [single-photon emission computed tomography] imaging) with a mandate to terminate all therapeutic development efforts for this product, and indeed, more broadly, for all cellular therapeutics near clinical application.…”