Kidney Tubular Necrosis, AcutePhase 1NCT00733876
Allogeneic Multipotent Stromal Cell Treatment for Acute Kidney Injury Following Cardiac Surgery
A Phase 1 study testing Multipotent Stromal Cells and Administration of MSC in people with Kidney Tubular Necrosis, Acute, run by AlloCure Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tubular Necrosis, Acute
- What is being tested?
- Multipotent Stromal Cells and Administration of MSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of ongoing local or systemic infection
- Younger than 18
- Participation in another clinical trial
- Pregnancy
- Contraindication to general anesthesia
- Prisoner
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intermountain Medical Center
Murray, Utah, 84157
St Mark's Hospital
Salt Lake City, Utah, 84124
About this study
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
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.
- Conditions
- Kidney Tubular Necrosis, Acute
- Being tested
- Multipotent Stromal Cells, Administration of MSC
- Keywords
- Acute Renal Failure Cardiac Surgery Stem Cell
- Medical subject headings
- Kidney Tubular Necrosis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multipotent Stromal CellsBiological
Post-operative administration of MSC
Administration of MSCBiological
Dose escalation protocol
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Biological: Multipotent Stromal Cells; Biological: Administration of MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of MSC-specific Adverse or Serious Adverse Events
Measured: In hospital, monthly x 6, yearly x 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2010
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Tubular Necrosis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AlloCure Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Intermountain Health Care, Inc., St Mark's Hospital Foundation
- Responsible party
- Sponsor
- Investigators
- Christof Westenfelder, MD, Study director, AlloCure Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733876
- Sponsor's protocol ID
- NG-IMC001
- Status last verified
- Aug 2014
- First submitted
- 11 Aug 2008
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30484934Westenfelder 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.
PubMed 25018910Togel 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.
PubMed 23036928
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00733876
- Acronym / sponsor ID
- NG-IMC001
- Conditions
- Kidney Tubular Necrosis, Acute
- Keywords
- Acute Renal Failure Cardiac Surgery Stem Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- AlloCure Inc.Industry (pharma, biotech, devices)
- Collaborators
- Intermountain Health Care, Inc., St Mark's Hospital Foundation
- Study start
- Aug 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: Multipotent Stromal Cells, Biological: Administration of MSC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- Presence of ongoing local or systemic infection
- Younger than 18
- Participation in another clinical trial
- Pregnancy
- Contraindication to general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multipotent Stromal CellsPost-operative administration of MSC | Biological | A |
| Administration of MSCDose escalation protocol | Biological | A |
Primary outcome
Absence of MSC-specific Adverse or Serious Adverse Events
Time frame: In hospital, monthly x 6, yearly x 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Derived from this study: PubMed 30484934Zhao 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.
- Derived from this study: PubMed 25018910Westenfelder 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.
- Derived from this study: PubMed 23036928Togel 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.
Related trials for Kidney Tubular Necrosis, Acute
Recruiting
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
Acute Kidney Injury
Not yet recruitingPhase 2/3
Use of QRX3 for Acute Tubular Necrosis Type of Renal Failure in Hospitalized Patients ( QRX-3 in ARF)
Acute Renal Failure (ARF), Acute Tubular Necrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christof Westenfelder, MD study director
AlloCure Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multipotent Stromal Cells and Administration of MSC in people with Kidney Tubular Necrosis, Acute, run by AlloCure Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of MSC-specific Adverse or Serious Adverse Events (time frame: In hospital, monthly x 6, yearly x 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00733876, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.