ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)

Lisata Therapeutics, Inc.150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Myocardial Ischemia

Eligibility

Sex: ALLMin age: 21 YearsMax age: 81 Years

Medical Language ↔ Plain English

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

Locations (23)

Cardiology, PC

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Data from ClinicalTrials.gov

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