Dose Arm 1 for Chronic Kidney Disease (CKD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic Florida, Jacksonville, FL
Chronic Kidney Disease (CKD)+2 More
Allogeneic adipose-derived mesenchymal stem cells (MSC) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to assess the safety and tolerability of intravenously delivered mesenchymal steml cells (MSC) in one of two fixed dosing regimens at two time points in patients with chronic kidney disease.

Eligible Conditions

  • Chronic Kidney Disease (CKD)

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 15 months

15 months
Adverse events and/or serious adverse events
6 months
Change in eGFR Value

Trial Safety

Trial Design

2 Treatment Groups

Dose Arm 1
1 of 2
Dose Arm 2
1 of 2
Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Dose Arm 1 · No Placebo Group · Phase 1

Dose Arm 1
Drug
Experimental Group · 1 Intervention: Allogeneic adipose-derived mesenchymal stem cells (MSC) · Intervention Types: Drug
Dose Arm 2
Drug
Experimental Group · 1 Intervention: Allogeneic adipose-derived mesenchymal stem cells (MSC) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 15 months
Closest Location: Mayo Clinic Florida · Jacksonville, FL
Photo of Jacksonville  1Photo of Jacksonville  2Photo of Jacksonville  3
2007First Recorded Clinical Trial
2 TrialsResearching Chronic Kidney Disease (CKD)
86 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an eGFR of 25-55 ml/min/1.73m2.
Albumin:creatinine ratio ≥300 mg/g or proteinuria ≥300 mg/day despite maximally tolerated dose of RAAS drugs (e.g
Hemoglobin A1c of ≤ 8% despite maximally tolerated anti-diabetes therapy.
You have the ability to give informed consent.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.