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Coronary Microvascular Dysfunction - Healing Genes
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Coronary Microvascular Dysfunction

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Safety and Potential Bioactivity of CLBS14 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS14 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease


Phase 2

DESCRIPTION:

Doctors at Cedars-Sinai Medical Center in CA and the Mayo Clinic in MN seek patients with coronary microvascular dysfunction and without obstructive coronary artery disease. The treatment selects particular immune T-cells that are have innate ability to repair small blood vessels for microcirculation, multiplies them outside the body, then re-administers them to the patient. In addition, an immune-stimulating medicine (GCSF) will be administered prior to the collection of stem cells to increase their numbers.

After GCSF medication, study participants will undergo a blood draw treatment that sorts out specific stem cells and returns the blood to the patient. After the cells are multiplied and re-infused, follow-up will last at least a year.


PATIENT MUST:

  • Be 18 years of age or older
  • Have no obstructive coronary artery disease
  • Not be pregnant or lactating

THE STUDY INVOLVES:

  1. Screening before the treatment
  2. Following GCSF medication, leukapheresis will draw the needed immune cells but return blood cells to the body.
  3. The gene-modified immune cells will be re-infused to the patient.
  4. The patient will be closely assessed during treatment, with follow-up for 1 year.

LOCATIONS AND CONTACTS:

Trials will take place at the Cedars-Sinai Medical Center in Los Angeles, CA, Map, and

Mayo Clinic in Rochester in Rochester, MN, Map.


Contacts:

Chrissy Kotynski  |  (908) 842-0093  |  [email protected]

Scott Volk  |  (949) 346-8784  |  [email protected]


SPONSOR INFORMATION:

Caladrius Biosciences, Inc.

National Heart, Lung, and Blood Institute (NHLBI)

Cedars-Sinai Medical Center

Mayo Clinic

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03508609

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