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Allogeneic Multipotent Stromal Cell Treatment for Acute Kidney Injury Following Cardiac Surgery

Primary Purpose

Kidney Tubular Necrosis, Acute

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Multipotent Stromal Cells

Administration of MSC

About this trial

This is an interventional treatment trial for Kidney Tubular Necrosis, Acute focused on measuring Acute Renal Failure Cardiac Surgery Stem Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Intermountain Medical Center
St Mark's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Absence of MSC-specific Adverse or Serious Adverse Events

Secondary Outcome Measures

Full Information

NCT ID

NCT00733876

First Posted

August 11, 2008

Last Updated

August 5, 2014

Sponsor

AlloCure Inc.

Collaborators

Intermountain Health Care, Inc., St Mark's Hospital Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00733876

Brief Title

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

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AlloCure Inc.

Collaborators

Intermountain Health Care, Inc., St Mark's Hospital Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Tubular Necrosis, Acute

Keywords

Acute Renal Failure Cardiac Surgery Stem Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Multipotent Stromal Cells

Intervention Description

Post-operative administration of MSC

Intervention Type

Biological

Intervention Name(s)

Administration of MSC

Intervention Description

Dose escalation protocol

Primary Outcome Measure Information:

Title

Absence of MSC-specific Adverse or Serious Adverse Events

Time Frame

In hospital, monthly x 6, yearly x 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christof Westenfelder, MD

Organizational Affiliation

AlloCure Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Intermountain Medical Center

City

Murray

State/Province

Utah

ZIP/Postal Code

84157

Country

United States

Facility Name

St Mark's Hospital

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30484934

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.

Results Reference

derived

PubMed Identifier

23036928

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.

Results Reference

derived

PubMed Identifier

25018910

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.

Results Reference

derived

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Allogeneic Multipotent Stromal Cell Treatment for Acute Kidney Injury Following Cardiac Surgery

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