Myocardial IschemiaNCT00545610
ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)
An observational study of Myocardial Ischemia, run by Lisata Therapeutics, Inc. at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 81 years
- Conditions the study is for
- Myocardial Ischemia
- How many people
- 150 participants
- Where
- 23 sitesUnited States
- Study dates
- Oct 2007to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have received treatment with Auto-CD34+ cells (1 x 10^5 (+/-10%) CD34+ cells/kg or 5 x 10^5 (+/-10%) CD34+ cells/kg)or with placebo (saline plus 5% autologous plasma) and who have completed the final study visit (Month 12) of the core therapeutic study 24779
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
The Medical Group of St. Joseph´s
Atlanta, Georgia
Cardiology, PC
Birmingham, Alabama
Caritas St. Elizabeth´s Medical Center
Boston, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts
Northwestern University Medical School
Chicago, Illinois
Rush University Medical Center
Chicago, Illinois
The Lindner Clinical Trial Center
Cincinnati, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio
Holy Cross Hospital
Fort Lauderdale, Florida
University of Florida
Gainesville, Florida
University of Iowa
Iowa City, Iowa
University of Florida Health Science Center
Jacksonville, Florida
Scripps Green Hospital / Scripps Clinical Hospital
La Jolla, California, 92037
University of Wisconsin Medical School
Madison, Wisconsin
Heart Care Associates, LLC
Milwaukee, Wisconsin
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Cornell University
New York, New York
New York Presbyterian Hospital
New York, New York
Cardiovascular Institute Florida Hospital
Orlando, Florida
Mayo Clinic Hospital
Phoenix, Arizona
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Stanford University Hospital and Clinics
Stanford, California
Washington Hospital Center
Washington D.C., District of Columbia
About this study
Official title: 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])
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
- Myocardial Ischemia
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Test 1 (n=50) | 1 x 10^5 (+/-10%) CD34+ cells/kg of body weight | |
| Test 2 (n=50) | 5 x 10^5 (+/-10%) CD34+ cells/kg of body weight | |
| Placebo (n=50) | Saline plus 5% autologous plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisata Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caladrius Study Director, Study director, Lisata Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545610
- Sponsor's protocol ID
- 34976
- Status last verified
- Nov 2018
- First submitted
- 16 Oct 2007
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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])
- ClinicalTrials.gov ID
- NCT00545610
- Acronym / sponsor ID
- 34976
- Conditions
- Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lisata Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test 1 (n=50) | – | –1 x 10^5 (+/-10%) CD34+ cells/kg of body weight |
| Test 2 (n=50) | – | –5 x 10^5 (+/-10%) CD34+ cells/kg of body weight |
| Placebo (n=50) | – | –Saline plus 5% autologous plasma |
Who may qualify
- Ages
- 21 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have received treatment with Auto-CD34+ cells (1 x 10^5 (+/-10%) CD34+ cells/kg or 5 x 10^5 (+/-10%) CD34+ cells/kg)or with placebo (saline plus 5% autologous plasma) and who have completed the final study visit (Month 12) of the core therapeutic study 24779
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caladrius Study Director study director
Lisata Therapeutics, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by Lisata Therapeutics, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.