Allogeneic Multipotent Stromal Cell Treatment for Acute Kidney Injury Following Cardiac Surgery
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ClinicalTrials.gov Identifier: NCT00733876 |
Recruitment Status :
Completed
First Posted : August 13, 2008
Last Update Posted : August 6, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Tubular Necrosis, Acute | Biological: Multipotent Stromal Cells Biological: Administration of MSC | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | August 2008 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Biological: Multipotent Stromal Cells
Post-operative administration of MSC Biological: Administration of MSC Dose escalation protocol |
- Absence of MSC-specific Adverse or Serious Adverse Events [ Time Frame: In hospital, monthly x 6, yearly x 3 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733876
United States, Utah | |
Intermountain Medical Center | |
Murray, Utah, United States, 84157 | |
St Mark's Hospital | |
Salt Lake City, Utah, United States, 84124 |
Study Director: | Christof Westenfelder, MD | AlloCure Inc. |
Responsible Party: | AlloCure Inc. |
ClinicalTrials.gov Identifier: | NCT00733876 |
Other Study ID Numbers: |
NG-IMC001 |
First Posted: | August 13, 2008 Key Record Dates |
Last Update Posted: | August 6, 2014 |
Last Verified: | August 2014 |
Acute Renal Failure Cardiac Surgery Stem Cell |
Acute Kidney Injury Kidney Tubular Necrosis, Acute Necrosis Renal Insufficiency |
Kidney Diseases Urologic Diseases Pathologic Processes |