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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00545610

Enrollment

150

Registered

2007-10-17

Start date

2007-10-31

Completion date

2010-06-30

Last updated

2018-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 81 Years

Healthy volunteers

Inclusion criteria

* Subjects who have received treatment with Auto-CD34+ cells or with placebo and who have completed the final study visit (Month 12) of the core therapeutic study 24779 * Subjects who are willing to comply with the specified follow-up evaluations in this study and to provide written informed consent to participate in this study

Design outcomes

Primary

Measure	Time frame
Long-term safety of intramyocardial injections of Auto-CD34+ cells relative to placebo for reducing the number of angina episodes in subjects with refractory chronic myocardial ischemia over a 12-month follow-up period.	12 months

Secondary

Measure	Time frame
Long-term efficacy of Auto-CD34+ cells relative to placebo for reducing the number of angina episodes in subjects with refractory chronic myocardial ischemia and the effects of this treatment on quality of life (QoL) over a 12-month follow-up period	12 months

Countries

United States

Outcome results