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Mesenchymal Stem Cell Therapy
Stem Cell Therapy for Chronic Kidney Disease
Phase 1
Waitlist Available
Led By LaTonya Hickson, MD
Research Sponsored by LaTonya J. Hickson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 30-80 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 months
Awards & highlights
Study Summary
This trial will test if it is safe to give people with chronic kidney disease mesenchymal stem cells, which may help treat the disease.
Who is the study for?
This trial is for adults aged 30-80 with chronic kidney disease, specifically those not on dialysis or with a transplant history. Participants must have certain levels of kidney function and protein in their urine, and can't be pregnant, heavy smokers, drug users, or have uncontrolled diseases like severe anemia.Check my eligibility
What is being tested?
The study tests the safety of using stem cells from fat tissue to treat chronic kidney disease. Patients will receive either one or two infusions of these cells to see how well they tolerate them and any potential benefits.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, immune system responses against the infused cells, general discomforts such as fever or fatigue. Since it's a new treatment being tested for safety, close monitoring for unexpected side effects is part of the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 30 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 22 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events and/or serious adverse events
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Arm 2Experimental Treatment1 Intervention
Subjects with chronic kidney disease will receive a single intravenous infusion of allogeneic adipose tissue-derived mesenchymal stem cells (MSC) of 150x10^6 cells at day 0.
Group II: Dose Arm 1Experimental Treatment1 Intervention
Subjects with chronic kidney disease will receive allogeneic adipose tissue-derived mesenchymal stem cells (MSC) in two intravenous infusions of 75x10^6 cells at day 0 and month 3.
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Who is running the clinical trial?
LaTonya J. HicksonLead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
LaTonya Hickson, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
24 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and give consent for treatment.I currently have an infection.I am between 30 and 80 years old.I have liver cirrhosis.If you use illegal drugs or drink a lot, or if you have mental health issues or unpredictable responsibilities, it might make it difficult for you to fully participate in the study.I haven't had a heart attack, stroke, or severe heart failure in the last 6 months and don't have uncontrolled heart rhythm problems.My kidney inflammation hasn't improved in 6 months or my protein loss in urine is very high.I have a history of blood clotting disorders.I do not have active hepatitis B, C, or HIV.You cannot or do not want to have MRI or CT scans.I currently have cancer.Your kidney function, as measured by eGFR, is between 25 and 55 ml/min/1.73m^2.Your blood pressure is consistently very low, with a reading of less than 85 mmHg for the top number (systolic) at the screening exam.My blood pressure is not higher than 155 mmHg.My weight is over 150 kg or my BMI is over 50.I have a diagnosed kidney condition such as lupus nephritis or amyloidosis.My urine test shows high protein levels, but I might be on RAAS inhibitors.You had an allergic reaction to blood transfusions or platelets in the past.I am on dialysis or have had a kidney transplant due to kidney failure.Your hemoglobin levels are below 9g/dL, indicating anemia.I have had an organ transplant.I have chronic obstructive pulmonary disease or asthma.I can attend all scheduled study visits without travel or physical restrictions.You currently smoke or use tobacco products.I have a genetic form of polycystic kidney disease.Your average blood sugar level, measured by HbA1c, is very high if you have diabetes.I am on strong medication to suppress my immune system.I have severe swelling, very low blood protein levels, and lose a lot of protein in my urine.I have had a kidney transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Arm 1
- Group 2: Dose Arm 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited for this trial?
"Yes, the current data posted on clinicaltrials.gov confirms that this medical study is actively recruiting participants. This research was first launched on October 7th 2021 and last updated November 9th 2022. The trial necessitates 40 patients from two different sites to be enrolled in order for it to successfully conclude."
Answered by AI
Are there any vacancies for study participants still available?
"Affirmative. According to the clinicaltrials.gov information, this medical study is currently gathering participants with first posting date of October 7th 2021 and last update on November 9th 2022. 40 patients need to be recruited from two distinct locations."
Answered by AI
Is the target population of this research project limited to individuals over 25 years of age?
"This trial is accepting participants aged between 30 and 80 years."
Answered by AI
Has the FDA sanctioned a single-dose approach utilizing allogeneic adipose-derived mesenchymal stem cells?
"We deem the safety of Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion to be a 1 due to being in Phase 1; there is minimal evidence that its safe and effective."
Answered by AI
Is it possible to become part of this experiment?
"Candidates hoping to be admitted into this research project must meet two requirements - they have a diagnosis of diabetes mellitus, type 2 and their age is between 30-80. Currently, the trial desires around 40 participants in total."
Answered by AI
Who else is applying?
What site did they apply to?
Mayo Clinic Florida
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
What questions have other patients asked about this trial?
When is the latest deadline to take part in this trial? When are the latest deadlines for taking part in the trial?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I have great hope in this therapy to improve my CVK condition. I see hope in this treatment and I believe it will help me enjoy my family for longer.
PatientReceived no prior treatments
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