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History of Changes for Study: NCT04614467
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction (FREEDOM)
Latest version (submitted July 11, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 29, 2020 None (earliest Version on record)
2 December 21, 2020 Study Status and Contacts/Locations
3 January 4, 2021 Study Status and Contacts/Locations
4 January 23, 2021 Contacts/Locations and Study Status
5 February 1, 2021 Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Outcome Measures and Study Identification
6 February 11, 2021 Contacts/Locations and Study Status
7 March 2, 2021 Contacts/Locations and Study Status
8 March 15, 2021 Contacts/Locations and Study Status
9 March 23, 2021 Contacts/Locations and Study Status
10 April 5, 2021 Contacts/Locations and Study Status
11 May 14, 2021 Study Status and Contacts/Locations
12 August 26, 2021 Study Status and Contacts/Locations
13 August 26, 2021 Contacts/Locations and Study Status
14 November 23, 2021 Contacts/Locations and Study Status
15 December 13, 2021 Contacts/Locations, Study Status, Eligibility and Outcome Measures
16 May 24, 2022 Recruitment Status, Study Status and Contacts/Locations
17 July 11, 2022 Study Status
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Study NCT04614467
Submitted Date:  October 29, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: CLBS16-P02
Brief Title: A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction (FREEDOM)
Official Title: A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CLBS16 Delivery by Intracoronary or Retrograde Coronary Sinus Administration in Subjects With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Recruiting
Study Start: October 28, 2020
Primary Completion: April 2022 [Anticipated]
Study Completion: October 2022 [Anticipated]
First Submitted: October 29, 2020
First Submitted that
Met QC Criteria:
October 29, 2020
First Posted: November 4, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 29, 2020
Last Update Posted: November 4, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Lisata Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous CD34+ cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single administration of CLBS16 or placebo.
Detailed Description:
Open or close this module Conditions
Conditions: Coronary Microvascular Dysfunction
Coronary Microvascular Disease
Microvascular Coronary Artery Disease
Keywords: angina
CMD
MVD
non-obstructive coronary artery disease
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 105 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: GCSF-mobilized autologous CD34+ cells, intracoronary infusion Biological: CLBS16
GCSF-mobilized autologous CD34+ cells
Experimental: GCSF-mobilized autologous CD34+ cells, retrograde infusion Biological: CLBS16
GCSF-mobilized autologous CD34+ cells
Placebo Comparator: Placebo via intracoronary infusion Biological: Placebo
isotonic solution (no CD34+ cells)
Placebo Comparator: Placebo via retrograde infusion Biological: Placebo
isotonic solution (no CD34+ cells)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from baseline in peak coronary flow reserve
[ Time Frame: Baseline to 6 months ]

2. Change from baseline in angina frequency
[ Time Frame: Baseline to 3 and 6 months ]

3. Change from baseline in total exercise time
[ Time Frame: Baseline to 6 months ]

4. Change from baseline in health-related quality of life (HRQoL)
[ Time Frame: Baseline to 3 and 6 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Men or women age ≥18
  • History of and currently experiencing angina at least 3 times per week
  • Prior diagnosis of CMD based on coronary flow reserve (CFR) ≤ 2.5
  • Peak CFR to intracoronary adenosine ≤ 2.5 at screening
  • Canadian Cardiovascular Society (CCS) class II, III or IV chronic refractory angina
  • No obstructive coronary artery disease
  • On stable medical therapy for at least 30 days prior to enrollment
  • Must agree to use a reliable and acceptable method of contraception for the duration of participation
  • Written informed consent

Exclusion Criteria:

  • Myocardial infarction within 90 days
  • Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
  • Diagnosis of other specific cardiac disease
  • Must meet LVEF and GFR requirements
  • Current use of coumadin or DOACs
  • Hypersensitivity to GCSF, apheresis or study product components
  • Positive for HIV, hepatitis B or hepatitis C
  • Active inflammatory or autoimmune disease, or chronic immunosuppressive state
  • Drug abuse
  • Pregnant or lactating
  • Malignant neoplasm within 5 years
  • History of Sickle Cell Disease
  • Participation in another clinical study within 90 days prior to informed consent or concurrently with this study
Open or close this module Contacts/Locations
Central Contact Person: Christine Kotynski
Telephone: 9088420093
Email: ckotynski@caladrius.com
Study Officials: Douglas W. Losordo, MD
Study Director
Lisata Therapeutics, Inc.
Locations: United States, Ohio
The Christ Hospital
[Recruiting]
Cincinnati, Ohio, United States, 45219
Contact:Contact: Darlene Rock, RN, MBA darlene.rock@thechristhospital.com
Contact:Principal Investigator: Timothy D. Henry, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Related Info
Available IPD/Information:

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