NCT03508609

Brief Summary

This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected 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 intracoronary infusion of CLBS16.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

April 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2020

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 8, 2021

Completed
Last Updated

January 8, 2021

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

April 16, 2018

Results QC Date

November 17, 2020

Last Update Submit

December 11, 2020

Conditions

Coronary Microvascular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Coronary Flow Reserve

    Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.

    Day 180

Secondary Outcomes (6)

  • Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine

    Day 180

  • Change From Baseline in Peripheral Arterial Tonometry

    Day 180

  • Change in Angina Frequency From Baseline

    6 months

  • Canadian Cardiovascular Society Angina Class

    6 months

  • Change From Baseline in Seattle Angina Questionnaire

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Autologous CD34 cells

EXPERIMENTAL

Open label active treatment arm. Subjects receive autologous CD34 cells.

Biological: CLBS16

Interventions

CLBS16BIOLOGICAL

GCSF-mobilized autologous CD34 cells

Autologous CD34 cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women age ≥18
  • History of and currently experiencing angina at least 3 times per week
  • No obstructive coronary artery disease
  • On stable medical therapy for 30 days prior to enrollment
  • Must agree to use a reliable and acceptable method of contraception for the duration of participation
  • Written informed consent

You may not qualify if:

  • 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 G-CSF, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Henry TD, Bairey Merz CN, Wei J, Corban MT, Quesada O, Joung S, Kotynski CL, Wang J, Lewis M, Schumacher AM, Bartel RL, Takagi H, Shah V, Lee A, Sietsema WK, Losordo DW, Lerman A. Autologous CD34+ Stem Cell Therapy Increases Coronary Flow Reserve and Reduces Angina in Patients With Coronary Microvascular Dysfunction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010802. doi: 10.1161/CIRCINTERVENTIONS.121.010802. Epub 2022 Jan 23.

    PMID: 35067072DERIVED

  • Rai B, Shukla J, Henry TD, Quesada O. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells. 2021 May 8;10(5):1137. doi: 10.3390/cells10051137.

    PMID: 34066713DERIVED

Results Point of Contact

Title
William Sietsema
Organization
Caladrius Biosciences, Inc.
bsietsema@caladrius.com
9495352391

Study Officials

  • Douglas W. Losordo, MD

    Chief Medical Officer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 26, 2018

Study Start

April 19, 2018

Primary Completion

December 10, 2019

Study Completion

May 5, 2020

Last Updated

January 8, 2021

Results First Posted

January 8, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)