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COMPLETED Phase 2

ACT34-CMI -- Adult Autologous CD34+ Cells

NCT00300053 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of CLBS14 in patients with refractory chronic myocardial ischemia.

Conditions Studied

Interventions

  • BIOLOGICAL CLBS14 (low-dose)
  • BIOLOGICAL CLBS14 (high-dose)
  • BIOLOGICAL placebo injection

Study Locations (20)

Florida

  • Holy Cross Hospital — Fort Lauderdale
  • University of Florida Health Science Center — Gainesville
  • University of Florida Health Science Center — Jacksonville
  • Central Florida Cardiology Group — Orlando

Arizona

  • Arizona Heart Institute — Phoenix
  • Mayo Clinic Hospital — Phoenix

California

  • Scripps Memorial Hospital — La Jolla
  • Stanford University Hospital and Clinics — Stanford

Illinois

  • Northwestern University Medical Center, Bluhm Cardiovascluar Institute — Chicago
  • Rush University Medical Center — Chicago

Massachusetts

  • Massachusetts General Hospital — Boston
  • Caritas Saint Elizabeth's Medical Center — Boston

New York

  • New York Presbyterian Hospital - Columbia University Medical Center — New York
  • New York Presbyterian Hospital - Weill Cornell Medical College of Cornell University — New York

Alabama

  • Cardiology PC — Birmingham

District of Columbia

  • Washington Hospital Center — Washington D.C.

Trial Details

FieldValue
Enrollment Target 321 participants
Start Date 2006-04
Est. Completion 2009-03
Phase Phase 2

Sponsor

Lisata Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00300053

The ClinicalTrials.gov registry entry for NCT00300053 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 321 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lisata Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Myocardial Ischemia appearing as the primary indexed condition, and to 3 interventions — of which CLBS14 (low-dose) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00300053 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00300053 about?

NCT00300053 is a clinical study titled "ACT34-CMI -- Adult Autologous CD34+ Cells". The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of CLBS14 in patients with refractory chronic myocardial ischemia.

What is the current status of trial NCT00300053?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 321 participants. The study started on 2006-04. Estimated completion is 2009-03.

What conditions does trial NCT00300053 study?

This clinical trial studies the following conditions: Myocardial Ischemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00300053?

The interventions under investigation include: CLBS14 (low-dose) (BIOLOGICAL), CLBS14 (high-dose) (BIOLOGICAL), placebo injection (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00300053?

This trial is sponsored by Lisata Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00300053 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial