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MSC for Occlusive Disease of the Kidney

Primary Purpose

Atherosclerotic Renal Artery Stenosis, Ischemic Nephropathy, Renovascular Hypertension

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Arterial infusion of autologous mesenchymal stem cells

About this trial

This is an interventional treatment trial for Atherosclerotic Renal Artery Stenosis focused on measuring renal artery stenosis, renovascular hypertension, ischemic nephropathy, chronic kidney disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

4.1 Inclusion Criteria

Are between ages 40 and 80 years old.
Advanced vascular occlusive disease (atherosclerosis) affecting one or both kidneys: defined as a) loss of parenchymal volume and renal blood flow (measured by MDCT as previously described (17) and/or duplex ultrasound velocity above 300 cm/sec to the affected kidney to be infused with MSC's.
Have serum creatinine below 2.5 mg/dL
Have no-contraindications to angiography: severe contrast allergy
Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
Ability to comply with protocol
Competent and able to provide written informed consent

4.2 Exclusion Criteria

Advanced CKD: Stage 5 (two kidney eGFR < 15 ml/min/1.73 m2) contralateral renal artery occlusion/stenosis above 75% or ESRD requiring dialysis
Clinically significant abnormalities on laboratory examination, including Bilirubin (> 2 x normal), platelets (<100 thousand), potassium (>5.5 mEq/L), and sodium (<130 mEq/L), ALT or AST more than 2 x normal, Prothrombin time (INR>1.4), Hemoglobin <10.0 g/dL.
Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure) that would, in the opinion of the investigators, compromise the safety of the patient.
Specific exclusions:
1. Clinical history of deep vein thrombosis within three months of MSC administration
2. Uncontrolled hypertension (Systolic BP >180 mmHg despite therapy)
3. Active infection
4. Reduced ejection fraction (below 30%)
5. Evidence of hepatitis B,C, or HIV
6. Diabetes treated with insulin and/or glucose lowering agents
7. Anemia (Hgb<10 g/dL)
8. Regular use of potentially renotoxic drugs, e.g. non-steroidal anti-inflammatory agents (NSAID's): (>2 x weekly)
History of cancer including melanoma (with the exception of localized skin cancers)
Investigational drug exposure within thirty (30) days of baseline
Beck's depression score above 16
Pregnant or breast feeding.
History of clinically significant auto-immunity or any previous example of fat-directed autoimmunity

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

infusion of autologous mesenchymal stem cells

Arm Description

Patients will undergo a subcutaneous fat biopsy for expansion of mesenchymal stromal (stem) cells (MSC) in the Human Cell Therapy Laboratory. Patients will be admitted to the inpatient Clinical Research Unit of the Mayo Clinic Center for 3 days prior to treatment, for pre-infusion tests. Renal angiography will be performed to deliver a single intra-arterial dose of MSC's into one affected kidney. Patients will be observed for 24 hours for acute adverse events. Patients will have remote visits at 1 week, 4 weeks,8 weeks, and 6 months. At 3 months, patients will return for repeat evaluation of kidney function, blood flow and structural alterations within the clinical research unit at St. Mary's Hospital, Rochester, Minnesota. Thereafter, health assessment and blood draws will be repeated at 12 and 24 months with urinary cytology and MRI.

Outcomes

Primary Outcome Measures

Renal blood flow and function in the treated kidneys.

Individual kidney blood flow, measured by multidetector CT contrast transit times, will be measured before and after MSC infusion.

Secondary Outcome Measures

Level of kidney function.

Level of kidney function will be assessed as glomerular filtration rate by iothalamate clearance. Tissue oxygenation within each kidney will be measured by Blood Oxygen Level Dependent (BOLD) magnetic resonance.

Full Information

NCT ID

NCT01840540

First Posted

April 23, 2013

Last Updated

August 4, 2017

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01840540

Brief Title

MSC for Occlusive Disease of the Kidney

Official Title

Phase I Study of Autologous Mesenchymal Stem Cells in the Treatment of Atherosclerotic Renal Artery Stenosis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To determine the safety and toxicity of intra-arterial infused autologous adipose derived mesenchymal stromal (stem) cells in patients with vascular occlusive disease of the kidney.

Detailed Description

Individuals with unilateral arterial occlusive disease will be treated to injured kidney with autologous cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerotic Renal Artery Stenosis, Ischemic Nephropathy, Renovascular Hypertension

Keywords

renal artery stenosis, renovascular hypertension, ischemic nephropathy, chronic kidney disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

infusion of autologous mesenchymal stem cells

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Arterial infusion of autologous mesenchymal stem cells

Other Intervention Name(s)

MSC

Primary Outcome Measure Information:

Title

Renal blood flow and function in the treated kidneys.

Description

Individual kidney blood flow, measured by multidetector CT contrast transit times, will be measured before and after MSC infusion.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Level of kidney function.

Description

Time Frame

2 years

Other Pre-specified Outcome Measures:

Title

Blood pressure levels.

Description

Blood pressure will be assessed by oscillometric measurement.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

4.1 Inclusion Criteria Are between ages 40 and 80 years old. Advanced vascular occlusive disease (atherosclerosis) affecting one or both kidneys: defined as a) loss of parenchymal volume and renal blood flow (measured by MDCT as previously described (17) and/or duplex ultrasound velocity above 300 cm/sec to the affected kidney to be infused with MSC's. Have serum creatinine below 2.5 mg/dL Have no-contraindications to angiography: severe contrast allergy Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia Ability to comply with protocol Competent and able to provide written informed consent 4.2 Exclusion Criteria Advanced CKD: Stage 5 (two kidney eGFR < 15 ml/min/1.73 m2) contralateral renal artery occlusion/stenosis above 75% or ESRD requiring dialysis Clinically significant abnormalities on laboratory examination, including Bilirubin (> 2 x normal), platelets (<100 thousand), potassium (>5.5 mEq/L), and sodium (<130 mEq/L), ALT or AST more than 2 x normal, Prothrombin time (INR>1.4), Hemoglobin <10.0 g/dL. Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure) that would, in the opinion of the investigators, compromise the safety of the patient. Specific exclusions: Clinical history of deep vein thrombosis within three months of MSC administration Uncontrolled hypertension (Systolic BP >180 mmHg despite therapy) Active infection Reduced ejection fraction (below 30%) Evidence of hepatitis B,C, or HIV Diabetes treated with insulin and/or glucose lowering agents Anemia (Hgb<10 g/dL) Regular use of potentially renotoxic drugs, e.g. non-steroidal anti-inflammatory agents (NSAID's): (>2 x weekly) History of cancer including melanoma (with the exception of localized skin cancers) Investigational drug exposure within thirty (30) days of baseline Beck's depression score above 16 Pregnant or breast feeding. History of clinically significant auto-immunity or any previous example of fat-directed autoimmunity

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Textor, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27515308

Citation

Camilleri ET, Gustafson MP, Dudakovic A, Riester SM, Garces CG, Paradise CR, Takai H, Karperien M, Cool S, Sampen HJ, Larson AN, Qu W, Smith J, Dietz AB, van Wijnen AJ. Identification and validation of multiple cell surface markers of clinical-grade adipose-derived mesenchymal stromal cells as novel release criteria for good manufacturing practice-compliant production. Stem Cell Res Ther. 2016 Aug 11;7(1):107. doi: 10.1186/s13287-016-0370-8.

Results Reference

derived

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MSC for Occlusive Disease of the Kidney

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