Back to resultsAMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Primary Purpose
End Stage Renal Disease
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adipose Derived Mesenchymal Stem Cells
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
Inclusion Criteria:
- Patient between 18 and 85 years old
- Patient currently planned for creation of an upper extremity AV fistula with suitable anatomy
- Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
- Life expectancy of at least 24 months
- If female, must be post-menopausal or not able to have children. Post-menopausal/non-child bearing status must be clearly documented in the medical record. If documentation of post-menopausal/non-child bearing status is not available then a pregnancy test must be performed.
Exclusion Criteria:
- Malignancy or treatment for malignancy within the previous 6 months
- Immunodeficiency including AIDS / HIV or Active autoimmune disease
- Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
- Treatment with any investigational drug/ device within 60 days prior to study entry or Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs and the AVF
- History of failed organ transplant on immunosuppression.
- Subjects with known active infection (infection which is being treated)
Sites / Locations
- Mayo Clinic in FloridaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adipose Derived Mesenchymal Stem Cells
Arm Description
Subjects diagnosed with End Stage Renal Disease (ESRD) and are currently on hemodialysis therapy with planned creation of a new upper extremity arteriovenous fistula will receive Adipose Derived Mesenchymal Stem Cells treatment.
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events
Evaluate the safety of AMSC administration by assessing the number of participants to experience an adverse event as defined by inflammation, infection (local or systemic), aneurysm formation, clinically significant increase or decrease in blood flow or thrombosis formation as evaluated through physical exam and ultrasound.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04392206
Brief Title
AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Official Title
A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Albert Hakaim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal 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
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adipose Derived Mesenchymal Stem Cells
Arm Type
Experimental
Arm Description
Subjects diagnosed with End Stage Renal Disease (ESRD) and are currently on hemodialysis therapy with planned creation of a new upper extremity arteriovenous fistula will receive Adipose Derived Mesenchymal Stem Cells treatment.
Intervention Type
Drug
Intervention Name(s)
Adipose Derived Mesenchymal Stem Cells
Other Intervention Name(s)
AMSC
Intervention Description
The dose will be specifically tailored to each subject's vascular anatomy determined by the surgeon through ultrasound measurements. Approximately 3-5 million cells in 5ml Ringer Lactate (RL) Solution
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Description
Evaluate the safety of AMSC administration by assessing the number of participants to experience an adverse event as defined by inflammation, infection (local or systemic), aneurysm formation, clinically significant increase or decrease in blood flow or thrombosis formation as evaluated through physical exam and ultrasound.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient between 18 and 85 years old
Patient currently planned for creation of an upper extremity AV fistula with suitable anatomy
Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
Life expectancy of at least 24 months
If female, must be post-menopausal or not able to have children. Post-menopausal/non-child bearing status must be clearly documented in the medical record. If documentation of post-menopausal/non-child bearing status is not available then a pregnancy test must be performed.
Exclusion Criteria:
Malignancy or treatment for malignancy within the previous 6 months
Immunodeficiency including AIDS / HIV or Active autoimmune disease
Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
Treatment with any investigational drug/ device within 60 days prior to study entry or Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs and the AVF
History of failed organ transplant on immunosuppression.
Subjects with known active infection (infection which is being treated)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reagan Dukes
Phone
(904) 953-2077
Email
Dukes.Reagan@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mauricia Buchanan
Phone
(904) 953-2077
Email
buchanan.mauricia@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Hakaim, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reagan Dukes
Phone
904-953-2077
Email
Dukes.Reagan@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
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