Clinical trial NCT00733876: Allogeneic Multipotent Stromal Cell Treatment for Acute Kidney Injury Following Cardiac Surgery
Official title: Phase I Clinical Trial, Dose-escalating Intra-aortic Infusion of Allogeneic , Bone Marrow-derived Multipotent Stromal Cells to Prevent and Treat Post-operative Acute Kidney Injury in Patients Who Require On-pump Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Tubular Necrosis, Acute
Keywords: Acute Renal Failure Cardiac Surgery Stem Cell
Lead sponsor: AlloCure Inc.
Sponsor class: INDUSTRY
Collaborators: name: Intermountain Health Care, Inc.
name: St Mark's Hospital Foundation
First posted: 2008-08-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine if the administration of allogeneic MSCs at defined doses is safe in patients who are at high risk of developing significant Acute Kidney Injury (AKI) after undergoing on-pump cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Documented ischemic coronary heart and/or valvular heart disease:Acceptable candidate for elective CABG and/or Cardiac Valve Surgery
* Patients at high risk for post-op AKI:Age 18 or older if at high risk for post-op AKI because of underlying Diabetes mellitus (type I or II), CHF, COPD Chronic Kidney Disease (CKD) stage 1-4
* Patients at high risk for post-op AKI :age \> 65 or combinations
* Patent femoral artery without aortic aneurysm
* Ability to give informed consent.

Exclusion Criteria:

* Presence of ongoing local or systemic infection
* Younger than 18
* Participation in another clinical trial
* Pregnancy
* Contraindication to general anesthesia
* Prisoner
* Dialysis patient (CKD-6) or patient with CKD-5
* History of malignancy except non-melanoma skin cancer
* Occluded Groin arteries
* Uncontrolled Diabetes mellitus (HbA1c \> 10, history of diabetic ketoacidosis or osmolar coma within the last three months)
* Non-healing foot ulcers.
* Clinical evidence of severe peripheral vascular disease (ABI \< 0.3)
* Coronary Angiogram \< 7 days before surgery
* Inadequate pre-operative time to obtain baseline kidney function data due to urgent/emergent surgery
* Unstable myocardium (evolving myocardial infarction), cardiogenic shock

Primary outcomes:
measure: Absence of MSC-specific Adverse or Serious Adverse Events
timeFrame: In hospital, monthly x 6, yearly x 3
Secondary outcomes:
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: St Mark's Hospital
state: Utah
Study officials:
affiliation: AlloCure Inc.
name: Christof Westenfelder, MD
role: STUDY_DIRECTOR
References:
citation: Zhao L, Hu C, Zhang P, Jiang H, Chen J. Preconditioning strategies for improving the survival rate and paracrine ability of mesenchymal stem cells in acute kidney injury. J Cell Mol Med. 2019 Feb;23(2):720-730. doi: 10.1111/jcmm.14035. Epub 2018 Nov 28.
citation: Togel FE, Westenfelder C. Kidney protection and regeneration following acute injury: progress through stem cell therapy. Am J Kidney Dis. 2012 Dec;60(6):1012-22. doi: 10.1053/j.ajkd.2012.08.034. Epub 2012 Oct 2.
citation: Westenfelder C, Togel FE. Protective actions of administered mesenchymal stem cells in acute kidney injury: relevance to clinical trials. Kidney Int Suppl (2011). 2011 Sep;1(3):103-106. doi: 10.1038/kisup.2011.24.