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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Tubular Necrosis, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Multipotent Stromal Cells

Intervention Type BIOLOGICAL

Post-operative administration of MSC

Administration of MSC

Intervention Type BIOLOGICAL

Dose escalation protocol

Interventions

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Multipotent Stromal Cells

Post-operative administration of MSC

Intervention Type BIOLOGICAL

Administration of MSC

Dose escalation protocol

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No