Trials / Completed
CompletedNCT00545610
ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)
A 12-Month Follow-Up Study to Protocol 24779 (A Double-blind, Prospective, Randomized, Placebo-controlled Study to Determine the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial Injections of G-CSF Mobilized Auto CD34+ Cells for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia [ACT34-CMI])
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Lisata Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 21 Years – 81 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this 12-month, observational, follow-up study is to collect additional data (by telephone contact) with which to assess the efficacy, safety, and effects of intramyocardial injections of adult autologous CD34+ cells on quality of life (QoL) in subjects with chronic refractory myocardial ischemia. No treatments will be administered during this study. However, the investigators and other study site personnel and the subjects will remain blinded to the treatment assignments from the core therapeutic study (# 24779) so as to provide a total of 24 months of blinded data.
Conditions
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2010-04-01
- Completion
- 2010-06-01
- First posted
- 2007-10-17
- Last updated
- 2018-11-28
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00545610. Inclusion in this directory is not an endorsement.