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

Lisata Therapeutics

Status

Completed

Conditions

Myocardial Ischemia

Study type

Observational

Funder types

Industry

Identifiers

NCT00545610

34976

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

21 to 81 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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