Renal Artery StenosisPhase 1NCT02266394
Hypoxia and Inflammatory Injury in Human Renovascular Hypertension
A Phase 1 study testing Mesenchymal stem cell and Mesenchymal stem cell delivery with stent placement in people with Renal Artery Stenosis and Ischemic Nephropathy, run by Mayo Clinic at 3 sites in United States.
Trial summary
Current treatments for ARAS based on restoring blood flow alone have been unsuccessful at recovering kidney function. For this reason we are studying a stem cell product called "mesenchymal stem cells" or MSC. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Renal Artery Stenosis, Ischemic Nephropathy, Renovascular Disease
- What is being tested?
- Mesenchymal stem cell and Mesenchymal stem cell delivery with stent placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Oct 2014to 25 Sep 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Creatinine <2.2 mg/dL for Caucasian males, <2.0 Caucasian females,< 2.4 African-American males, <2.1 mg/dL African-American females
- Hypertension (Systolic BP>155 mm Hg) and/or requirement for two or more antihypertensive medications: no restrictions on antihypertensive agents, although loop diuretics will be changed to diluting site agents (e.g. hydrochlorothiazide, indapamide, metolazone) prior to study.
- Angiotensin Converting Enzyme (ACE inhibitor) or Angiotensin Receptor Blocker (ARB) therapy maintained or initiated at usual recommended daily dose (equivalent: 40 mg lisinopril) .
Who cannot join
- Diabetes requiring insulin or oral hypoglycemic medications (see text)
- Known allergy to furosemide or iodinated intravenous contrast
- Pregnancy
- Recent Cardiovascular event: Myocardial infarction, stroke, congestive heart failure within 3 months
- Cardiac ejection fraction less than 30%
- Evidence of hepatitis B or C, or HIV infection
Show all 13Show fewer
- requirement for potentially nephrotoxic drugs, e.g. non-steroidal anti-inflammatory drugs
- Uncontrolled hypertension: SBP >180 mm Hg, despite antihypertensive therapy
- Kidney transplant
- Pacemaker, implantable defibrillator or other contraindication to Magnetic resonance imaging
- Inability to comply with breath-hold for 30 seconds
- History of deep venous thrombosis within 3 months of enrollment
- contraindications to renal biopsy including artificial valve requiring continuous anticoagulation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama
Birmingham, Alabama, 35294
University of Mississippi
Jackson, Mississippi, 39216
Mayo Clinic
Rochester, Minnesota, 55902
About this study
Official title: Hypoxia and Inflammatory Injury in Human Renovascular Hypertension : Phase 1 Trial of Mesenchymal Stem Cell Therapy
Current treatments for ARAS based on restoring blood flow alone have been unsuccessful at recovering kidney function. For this reason we are studying a stem cell product called "mesenchymal stem cells" or MSC. Mesenchymal stem cells (MSC) are grown from a person's own fat tissue (obtained as a fat biopsy) and infused back into the patient's own kidney.
This study is also being done to determine if the MSC infusion prior to percutaneous transluminal renal angioplasty with stenting (PTRA) further enhances changes in single kidney blood flow and restoration of kidney function, as well as to assess the relationship between MSC dose and measures of kidney function.
Read the detailed description
These studies include participation by human subjects using a 3-day inpatient CRU protocol at St. Mary's Hospital. Studies include formal measurement of blood and urinary markers of kidney function, BOLD MR and multidetector CT scanning. Forty-two non-diabetic patients between 40 and 80 years of any race or ethnicity will be recruited. All will have hypertension (defined as BP≥140/90 mmHg or ongoing antihypertensive drug therapy) but will have less than 180 mmHg to be included (with or without drug therapy). These subjects will be free of cardiovascular events within 3 months and will not have implanted electrical devices, such as a pacemaker or defibrillator. All patients will have identified large vessel renovascular disease (RVD) for Aims 1, 2 and 3. At least 10% of these subjects will be of African-American descent (self-identified) and recruited in collaboration with the University of Mississippi under the direction of Dr. Luis Juncos and the University of Alabama under the direction of Dr. David Calhoun. For completion of Aims 2 and 3, a three-day evaluation will be repeated between three and four months later, and ongoing safety and imaging studies will be performed up to 24 months after MSC administration. Participants in these protocols will undergo transvenous kidney biopsy under the direction of Drs. McKusick and Misra and their colleagues in Interventional Radiology. All subjects for these studies will complete the research plan at Mayo Clinic, Rochester, Minnesota.
- Being tested
- Mesenchymal stem cell, Mesenchymal stem cell delivery with stent placement
- Medical subject headings
- Renal Artery Obstruction, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellDrug
Also called Mesenchymal stem cell delivery
Intra-arterial infusion of the single-dose MSC
Mesenchymal stem cell delivery with stent placementProcedure or surgery
Intra-arterial stent placement after Mesenchymal stem cell infusion
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell delivery | Active comparator | To determine hemodynamic and immunologic changes associated with intra-renal delivery of adipose-derived MSC into human subjects with advanced RVD. Receives: Drug: Mesenchymal stem cell |
| Mesenchymal stem cell delivery with stent placement | Active comparator | To test adjunctive delivery of MSC to individuals with advanced RVD undergoing renal artery stenting. Receives: Drug: Mesenchymal stem cell; Procedure: Mesenchymal stem cell delivery with stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kidney function
Renal Tissue oxygenation
Measured: 3 months
Safety of Mesenchymal stem cell infusion
Number of patients with tissue injury markers
Measured: 2 years
Secondary outcomes (1)
Decrease in Kidney inflammation
Venous and tissue biomarkers of inflammation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start21 Oct 2014
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Artery StenosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mississippi Medical Center, University of Alabama at Birmingham
- Responsible party
- Principal investigator, Stephen C. Textor, M.D., Mayo Clinic
- Investigators
- Stephen C Textor, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266394
- Sponsor's protocol ID
- 14-002799
- Status last verified
- Jan 2021
- First submitted
- 18 Sep 2014
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Al Saeedi M, Abdurakhimova DA, Arabi T, Nyvad J, Oudih M, Xing L, Lu B, Zhang L, Zhu X, Misra S, Lerman A, Lerman LO. Association between CT-evaluated Poststenotic Dilatation in Human Renal Artery Stenosis and Kidney Release of MCP-1. Radiology. 2026 Apr;319(1):e252637. doi: 10.1148/radiol.252637.
PubMed 42048594Lerman LO. Cell-based regenerative medicine for renovascular disease. Trends Mol Med. 2021 Sep;27(9):882-894. doi: 10.1016/j.molmed.2021.06.004. Epub 2021 Jun 25.
PubMed 34183258
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia and Inflammatory Injury in Human Renovascular Hypertension : Phase 1 Trial of Mesenchymal Stem Cell Therapy
- ClinicalTrials.gov ID
- NCT02266394
- Acronym / sponsor ID
- 14-002799
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Mississippi Medical Center, University of Alabama at Birmingham
- Study start
- 21 Oct 2014 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 17 Oct 2014 (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.
Current treatments for ARAS based on restoring blood flow alone have been unsuccessful at recovering kidney function. For this reason we are studying a stem cell product called "mesenchymal stem cells" or MSC. Mesenchymal stem cells (MSC) are grown from a person's own fat tissue (obtained as a fat biopsy) and infused back into the patient's own kidney.
This study is also being done to determine if the MSC infusion prior to percutaneous transluminal renal angioplasty with stenting (PTRA) further enhances changes in single kidney blood flow and restoration of kidney function, as well as to assess the relationship between MSC dose and measures of kidney function.
Detailed description
These studies include participation by human subjects using a 3-day inpatient CRU protocol at St. Mary's Hospital. Studies include formal measurement of blood and urinary markers of kidney function, BOLD MR and multidetector CT scanning. Forty-two non-diabetic patients between 40 and 80 years of any race or ethnicity will be recruited. All will have hypertension (defined as BP≥140/90 mmHg or ongoing antihypertensive drug therapy) but will have less than 180 mmHg to be included (with or without drug therapy). These subjects will be free of cardiovascular events within 3 months and will not have implanted electrical devices, such as a pacemaker or defibrillator. All patients will have identified large vessel renovascular disease (RVD) for Aims 1, 2 and 3. At least 10% of these subjects will be of African-American descent (self-identified) and recruited in collaboration with the University of Mississippi under the direction of Dr. Luis Juncos and the University of Alabama under the direction of Dr. David Calhoun. For completion of Aims 2 and 3, a three-day evaluation will be repeated between three and four months later, and ongoing safety and imaging studies will be performed up to 24 months after MSC administration. Participants in these protocols will undergo transvenous kidney biopsy under the direction of Drs. McKusick and Misra and their colleagues in Interventional Radiology. All subjects for these studies will complete the research plan at Mayo Clinic, Rochester, Minnesota.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell delivery | Active comparator | Drug: Mesenchymal stem cellTo determine hemodynamic and immunologic changes associated with intra-renal delivery of adipose-derived MSC into human subjects with advanced RVD. |
| Mesenchymal stem cell delivery with stent placement | Active comparator | Drug: Mesenchymal stem cell, Procedure: Mesenchymal stem cell delivery with stent placementTo test adjunctive delivery of MSC to individuals with advanced RVD undergoing renal artery stenting. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Creatinine <2.2 mg/dL for Caucasian males, <2.0 Caucasian females,< 2.4 African-American males, <2.1 mg/dL African-American females
- Hypertension (Systolic BP>155 mm Hg) and/or requirement for two or more antihypertensive medications: no restrictions on antihypertensive agents, although loop diuretics will be changed to diluting site agents (e.g. hydrochlorothiazide, indapamide, metolazone) prior to study.
- Angiotensin Converting Enzyme (ACE inhibitor) or Angiotensin Receptor Blocker (ARB) therapy maintained or initiated at usual recommended daily dose (equivalent: 40 mg lisinopril) .
Key exclusion criteria (13 listed)
- Diabetes requiring insulin or oral hypoglycemic medications (see text)
- Known allergy to furosemide or iodinated intravenous contrast
- Pregnancy
- Recent Cardiovascular event: Myocardial infarction, stroke, congestive heart failure within 3 months
- Cardiac ejection fraction less than 30%
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 |
|---|---|---|
| Mesenchymal stem cellAlso: Mesenchymal stem cell deliveryIntra-arterial infusion of the single-dose MSC | Drug | Mesenchymal stem cell delivery, Mesenchymal stem cell delivery with stent placement |
| Mesenchymal stem cell delivery with stent placementIntra-arterial stent placement after Mesenchymal stem cell infusion | Procedure or surgery | Mesenchymal stem cell delivery with stent placement |
Primary outcome
Change in Kidney function
Time frame: 3 months
Renal Tissue oxygenation
Safety of Mesenchymal stem cell infusion
Time frame: 2 years
Number of patients with tissue injury markers
1 secondary outcome
Decrease in Kidney inflammation
Time frame: 3 months
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 27 Jan 2021.
- Derived from this study: PubMed 42048594Al Saeedi M, Abdurakhimova DA, Arabi T, Nyvad J, Oudih M, Xing L, Lu B, Zhang L, Zhu X, Misra S, Lerman A, Lerman LO. Association between CT-evaluated Poststenotic Dilatation in Human Renal Artery Stenosis and Kidney Release of MCP-1. Radiology. 2026 Apr;319(1):e252637. doi: 10.1148/radiol.252637.
- Derived from this study: PubMed 34183258Lerman LO. Cell-based regenerative medicine for renovascular disease. Trends Mol Med. 2021 Sep;27(9):882-894. doi: 10.1016/j.molmed.2021.06.004. Epub 2021 Jun 25.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Stephen C Textor, M.D. principal investigator
Mayo Clinic
3 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 Mesenchymal stem cell and Mesenchymal stem cell delivery with stent placement in people with Renal Artery Stenosis and Ischemic Nephropathy, run by Mayo Clinic at 3 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 3 inclusion and 13 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Change in Kidney function (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT02266394, which also lists 2 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 27 Jan 2021.