MSC for Occlusive Disease of the Kidney
This study is currently recruiting participants.
Verified May 2013 by Mayo Clinic
Information provided by (Responsible Party):
Stephen C. Textor, M.D., Mayo Clinic
First received: April 23, 2013
Last updated: May 8, 2013
Last verified: May 2013
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.
Atherosclerotic Renal Artery Stenosis
Repair of Renal Microvasculature
Drug: Arterial infusion of autologous mesenchymal stem cells
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Autologous Mesenchymal Stem Cells in the Treatment of Atherosclerotic Renal Artery Stenosis|
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Renal blood flow and function in the treated kidneys. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
Other Outcome Measures:
- Blood pressure levels. [ Time Frame: 2 years ] [ Designated as safety issue: No ]Blood pressure will be assessed by oscillometric measurement.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Arterial infusion of autologous mesenchymal stem cells
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|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840540
|Contact: Stephen C. Textor, MDfirstname.lastname@example.org|
|Contact: Beverly K. Tietje, Associatesemail@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Beverly K Tietje, Associate 507-255-0401 firstname.lastname@example.org|
|Principal Investigator: Stephen C Textor, M.D.|
Sponsors and Collaborators
|Principal Investigator:||Stephen Textor, MD||Mayo Clinic|