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

August 5, 2014 updated by: AlloCure Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84124
        • St Mark's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Biological: Multipotent Stromal Cells
Post-operative administration of MSC
Biological: Administration of MSC
Dose escalation protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of MSC-specific Adverse or Serious Adverse Events
Time Frame: In hospital, monthly x 6, yearly x 3
In hospital, monthly x 6, yearly x 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AlloCure Inc.

Collaborators

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

Investigators

  • Study Director: Christof Westenfelder, MD, AlloCure Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (ESTIMATE)

August 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NG-IMC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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