MSC for Occlusive Disease of the Kidney

NCT01840540 | Completed Phase 1

• 1 other identifier: 12-009298
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Renal Artery Stenosis; Ischemic Nephropathy; Renovascular Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Level of kidney function.

  2 years

Other Outcomes (1)

• Blood pressure levels.

  2 years

Study Arms (1)

infusion of autologous mesenchymal stem cells

EXPERIMENTAL

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.

Drug: Arterial infusion of autologous mesenchymal stem cells

Interventions

Arterial infusion of autologous mesenchymal stem cells DRUG

Also known as: MSC

infusion of autologous mesenchymal stem cells

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 27515308 DERIVED

MeSH Terms

Conditions

Hypertension, Renovascular; Renal Artery Obstruction; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Hypertension, Renal; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Textor, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 25, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2017
• Last Updated: August 7, 2017

Record last verified: 2017-08

Locations

US (1)