MSC Therapy for Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment using mesenchymal stem cells (MSC) to determine its safety and tolerability for people with chronic kidney disease. Participants will receive MSC through intravenous infusions, and the study explores two different dosing schedules to identify the more effective one. Individuals with chronic kidney disease who experience symptoms like protein in the urine or reduced kidney function despite treatment may be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, it mentions that participants should be on the maximally tolerated dose of certain medications for kidney disease and diabetes, suggesting you may need to continue those.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mesenchymal stem cells (MSCs) might help treat chronic kidney disease. In animal studies, such as those with rodents, MSCs improved kidney function. Importantly, these studies did not reveal any immediate side effects, suggesting that MSCs might be safe for humans as well.
In one case involving a cat, several MSC injections caused no immediate side effects. This is encouraging as it provides early evidence of safety, even though it involves a different species.
Although the study remains in an early phase and primarily focuses on safety, past research offers hope that MSCs are well-tolerated. It is important to remember that more research is needed to fully understand the safety and potential side effects in humans. However, the early findings are promising.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using allogeneic adipose-derived mesenchymal stem cells (MSC) for chronic kidney disease because these cells have the potential to regenerate damaged kidney tissue, a capability not present in standard treatments like blood pressure medications or dialysis. Unlike traditional therapies that primarily manage symptoms, MSC therapy directly targets the underlying damage to kidney cells. Additionally, MSCs are delivered intravenously, allowing them to potentially repair and reduce inflammation in the kidneys more effectively. This innovative approach could transform how we treat kidney diseases by promoting actual tissue healing rather than just symptom control.
What evidence suggests that this treatment might be an effective treatment for chronic kidney disease?
Research has shown that certain stem cells, called mesenchymal stem cells (MSCs), might improve kidney function in people with chronic kidney disease (CKD). Animal studies have found that MSCs enhance kidney function by improving their ability to filter blood. These stem cells also reduce inflammation and improve overall kidney health in various tests. Some case reports and analyses have shown promising results, suggesting that MSCs might lower the risk of CKD and improve kidney health markers, such as serum creatinine, a waste product used to assess kidney function. Although more research in humans is needed, these early findings suggest that MSC therapy could benefit CKD. In this trial, participants will receive allogeneic bone marrow-derived MSCs in different dosages, with one group receiving two infusions and another group receiving a single infusion, to evaluate their effects on kidney function.12345
Who Is on the Research Team?
LaTonya Hickson, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Adults aged 30-80 with chronic kidney disease, having specific levels of kidney function and protein in urine despite certain medications, can join. They must be able to consent and not have severe anemia, recent heart issues, liver cirrhosis, or a history of significant infections like hepatitis B/C or HIV. Pregnant individuals or those unwilling to use contraception post-treatment are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive allogeneic bone marrow-derived mesenchymal stem cells (MSC) in one of two dosing regimens: two intravenous infusions of 100x10^6 cells at time zero and three months, or a single intravenous infusion of 200x10^6 cells
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and changes in eGFR
What Are the Treatments Tested in This Trial?
Interventions
- Allogeneic adipose-derived mesenchymal stem cells (MSC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
LaTonya J. Hickson
Lead Sponsor