Biomedical Engineering Reference
In-Depth Information
Table 7.2
Clinical trials of cell therapy in cardiovas
cular disease
Indications
Type of cell and procedure
Trial
Sponsor
Angina pectoris
refractory to
treatment
Vescell
™
: autologous angiogenic cell precursors isolated from
blood, expanded in the laboratory and injected into the
coronary arteries via catheter
Open trial
Theravitae Ltd
Angina pectoris
(severe and
chronic)
Injection into the heart of autologous purified CD-34 cells to spur
regrowth of small blood vessels that constitute the
microcirculation of the heart
Open trial
Northwestern University
(Chicago, IL)
Angina pectoris
NOGA XP cardiac navigation system used to inject a patient's own
stem cells into his/her heart
Open trial
Cleveland Clinic, Ohio
Chronic myocardial
ischemia
Autologous cellular therapy (ACT): blood-derived CD34+ stem
cells injected directly into specific area of the heart muscle by
NOGA
®
XP catheter
Phase II
University of Pittsburgh Medical
Center (Pittsburgh, PA)
Chronic myocardial
ischemia
t2c001-AMI: intracoronary infusion of autologous bone marrow-
derived progenitor cells
Phase I/II
t2cure/Goethe-University
(Frankfurt)
Chronic myocardial
ischemia
Autologous cellular therapy (ACT): blood-derived CD34+ stem
cells, mobilized by G-CSF and sorted by Isolex (Baxter), injected
directly into specific area of the heart muscle by NOGA
®
XP catheter. Results: relief of angina and reduced mortality
Phase II,
double-blind,
placebo
controlled
Baxter/Minneapolis Heart Institute,
(Minneapolis, MN) Northwestern
Mem Hospital (Chicago, IL)
Chronic myocardial
ischemia
ACT34-CMI in patients who are currently on maximal medical
therapy and are not suitable candidates for conventional
procedures. CD34+ stem cells isolated using Baxter's ISOLEX
300i magnetic cell selection system
Phase II,
double-blind,
placebo-
controlled
Columbia University Medical Center,
New York
Chronic myocardial
ischemia
PRECISE study evaluates safety and feasibility of Celution stem
and regenerative cell processing system for autologous
adipose-derived stem cells to be reinjected into damaged heart
Phase II,
randomized
Cytori Therapeutics/Hospital
Gregorio Maranon (Madrid,
Spain)
Chronic myocardial
ischemia/coronary
artery disease
Autologous cellular therapy CD34-chronic myocardial ischemia
(ACT34-CMI) to test efficacy, tolerability, and safety of
CD34 + HSCs
Phase II
Rush University Medical Center
(Chicago, IL)
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