Allogeneic Multipotent Stromal Cell Treatment for Acute Kidney Injury Following Cardiac Surgery
This study has been completed.
Sponsor:
AlloCure Inc.
Collaborators:
Intermountain Health Care, Inc.
St Mark's Hospital Foundation
Information provided by (Responsible Party):
AlloCure Inc.
ClinicalTrials.gov Identifier:
NCT00733876
First received: August 11, 2008
Last updated: August 5, 2014
Last verified: August 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Tubular Necrosis, Acute |
Biological: Multipotent Stromal Cells Biological: Administration of MSC |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by AlloCure Inc.:
Primary Outcome Measures:
- Absence of MSC-specific Adverse or Serious Adverse Events [ Time Frame: In hospital, monthly x 6, yearly x 3 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 15 |
| Study Start Date: | August 2008 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Biological: Multipotent Stromal Cells
Post-operative administration of MSC
Biological: Administration of MSC
Dose escalation protocol
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733876
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733876
Locations
| United States, Utah | |
| Intermountain Medical Center | |
| Murray, Utah, United States, 84157 | |
| St Mark's Hospital | |
| Salt Lake City, Utah, United States, 84124 | |
Sponsors and Collaborators
AlloCure Inc.
Intermountain Health Care, Inc.
St Mark's Hospital Foundation
Investigators
| Study Director: | Christof Westenfelder, MD | AlloCure Inc. |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AlloCure Inc. |
| ClinicalTrials.gov Identifier: | NCT00733876 History of Changes |
| Other Study ID Numbers: | NG-IMC001 |
| Study First Received: | August 11, 2008 |
| Last Updated: | August 5, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AlloCure Inc.:
|
Acute Renal Failure Cardiac Surgery Stem Cell |
Additional relevant MeSH terms:
|
Acute Kidney Injury Necrosis Kidney Cortex Necrosis Kidney Tubular Necrosis, Acute |
Renal Insufficiency Kidney Diseases Urologic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on September 28, 2016