Allogeneic Multipotent Stromal Cell Treatment for Acute K... | NCT00733876

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

NCT00733876

Sponsor

AlloCure Inc.

Status

Completed

Last Update Posted

Aug 6, 2014Estimated

Enrollment

15Estimated

Phase

Phase 1

Conditions

Kidney Tubular Necrosis, Acute

Interventions

Multipotent Stromal Cells
Administration of MSC

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

May 2010Actual

Completion Date

Oct 2013Actual

First Submitted Date

Aug 11, 2008

First Submission Date that Met QC Criteria

Aug 11, 2008

First Posted Date

Aug 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2014

Last Update Posted Date

Aug 6, 2014Estimated

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Label	Type	Description	Intervention Names
A	Experimental		Biological: Multipotent Stromal Cells Biological: Administration of MSC

Name	Type	Description	Arm Group Labels	Other Names
Multipotent Stromal Cells	Biological	Post-operative administration of MSC	A

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Christof Westenfelder, MD	AlloCure Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Intermountain Medical Center		Murray	Utah	84157	United States
St Mark's Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30484934	Derived	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.
25018910	Derived	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.

ID	Term
D058186	Acute Kidney Injury
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases