NCT00733876

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_1

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

Study Start

First participant enrolled

August 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

1.7 years

First QC Date

August 11, 2008

Last Update Submit

August 5, 2014

Conditions

Kidney Tubular Necrosis, Acute

Keywords

Acute Renal Failure Cardiac Surgery Stem Cell

Outcome Measures

Primary Outcomes (1)

  • Absence of MSC-specific Adverse or Serious Adverse Events

    In hospital, monthly x 6, yearly x 3

Study Arms (1)

A

EXPERIMENTAL
Biological: Multipotent Stromal CellsBiological: Administration of MSC

Interventions

Multipotent Stromal CellsBIOLOGICAL

Post-operative administration of MSC

A
Administration of MSCBIOLOGICAL

Dose escalation protocol

A

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

St Mark's Hospital

Salt Lake City, Utah, 84124, United States

Location

Related Publications (3)

  • 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.

    PMID: 30484934DERIVED

  • 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.

    PMID: 25018910DERIVED

  • 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.

    PMID: 23036928DERIVED

MeSH Terms

Conditions

Kidney Tubular Necrosis, Acute

Condition Hierarchy (Ancestors)

Acute Kidney InjuryRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Christof Westenfelder, MD

    AlloCure Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

August 1, 2008

Primary Completion

May 1, 2010

Study Completion

October 1, 2013

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

US(2)