AMSC for Kidney Failure

Overseen By Reagan Dukes

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Houssam Farres, M.D.

Must not be taking: Immunosuppressants, Investigational drugs

Disqualifiers: Malignancy, Immunodeficiency, Hypercoagulable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate (during procedure)

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using adipose-derived mesenchymal stem cells to assist people with kidney failure on dialysis. The goal is to determine if this treatment can safely enhance the success of new dialysis access points in the arm. This trial suits individuals with end-stage renal disease on dialysis who plan to have a new access point created in their arm. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial staff to get a clear answer.

Is there any evidence suggesting that Adipose Derived Mesenchymal Stem Cells are likely to be safe for humans?

Research has shown that treatments using Adipose Derived Mesenchymal Stem Cells (AMSC) have been studied for kidney problems. In these studies, AMSCs have demonstrated potential in protecting kidneys by reducing damage, inflammation, and oxidative stress (an imbalance between harmful molecules and antioxidants).

Regarding safety, AMSCs have been well-tolerated in various research settings. Although most safety information comes from animal studies or different human conditions, evidence suggests they are generally safe. As this is a Phase 1 trial, the primary goal is to test safety in humans, with participants closely monitored for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for kidney failure, which often involve managing symptoms through dialysis or awaiting a transplant, adipose-derived mesenchymal stem cells (AMSCs) offer a new approach by potentially promoting kidney repair and regeneration. These stem cells are taken from fat tissue and have the unique ability to transform into various cell types, potentially aiding in tissue repair and reducing inflammation. Researchers are excited about AMSCs because they could improve kidney function and enhance the quality of life for patients with end-stage renal disease, offering a regenerative solution rather than just symptom management.

What evidence suggests that Adipose Derived Mesenchymal Stem Cells might be an effective treatment for kidney failure?

Research has shown that special cells taken from fat tissue, called adipose-derived mesenchymal stem cells (AMSCs), may help treat kidney problems. These cells can lower immune system activity, which benefits people with kidney disease. Studies suggest that AMSCs can repair kidneys and improve their function, crucial for preventing severe kidney failure. In early studies, using AMSCs in people with chronic kidney disease did not cause any harmful effects, indicating likely safety. These initial findings support the potential of AMSCs to improve kidney health, which is why researchers are considering them in this trial for treating kidney failure. Participants in this trial will receive AMSC treatment to evaluate its effectiveness and safety in individuals with end-stage renal disease. ^{1 3 4 5 6}

Who Is on the Research Team?

Houssam Farres, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with chronic kidney failure who need a new hemodialysis access point and have a life expectancy of over 2 years. Participants must be able to follow the study plan, give informed consent, and women must be unable to bear children or post-menopausal. People can't join if they've been in another drug/device study recently, have active infections, cancer treatments within 6 months, immune system problems like HIV/AIDS or autoimmune diseases, or a history of blood clotting issues.

Inclusion Criteria

I can communicate clearly, understand the study, and follow all procedures.

I am scheduled for a procedure to create a vein-artery connection in my arm.

You are expected to live for at least 2 years.

Exclusion Criteria

I have not had cancer or cancer treatment in the last 6 months.

I am currently being treated for an active infection.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Adipose Derived Mesenchymal Stem Cells during the creation of a new upper extremity arteriovenous fistula

Immediate (during procedure)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Adipose Derived Mesenchymal Stem Cells

Trial Overview The trial is testing the safety and effectiveness of injecting Adipose Derived Mesenchymal Stem Cells (AMSC) during surgery to create an arteriovenous fistula for dialysis. The goal is to see if AMSCs help the new connection mature better and stay open without blockages.

How Is the Trial Designed?

Group I: Adipose Derived Mesenchymal Stem Cells Experimental Treatment 1 Intervention

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.

Adipose Derived Mesenchymal Stem Cells is already approved in United States, European Union for the following indications:

Approved in United States as Adipose Derived Mesenchymal Stem Cells for:

• Orthopedic conditions
• Degenerative disc disease
• Arthritis
• Musculoskeletal issues
• Diabetes mellitus type 1 and 2
• Ischemic stroke
• Multiple sclerosis
• Myocardial ischemia
• Coronary arteriosclerosis
• Limb ischemia
• Obesity
• Fatty liver disease
• Muscular dystrophy
• Osteoarthritis
• Crohn's disease
• Cancers
• Acute kidney injury
• Chronic skin wounds
• Glioma

Approved in European Union as Adipose Derived Mesenchymal Stem Cells for:

• Orthopedic conditions
• Degenerative disc disease
• Arthritis
• Musculoskeletal issues
• Diabetes mellitus type 1 and 2
• Ischemic stroke
• Multiple sclerosis
• Myocardial ischemia
• Coronary arteriosclerosis
• Limb ischemia
• Obesity
• Fatty liver disease
• Muscular dystrophy
• Osteoarthritis
• Crohn's disease
• Cancers
• Acute kidney injury
• Chronic skin wounds
• Glioma

Who Is Running the Clinical Trial?

Houssam Farres, M.D.

Lead Sponsor

Trials

1

Recruited

20+

Albert Hakaim

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Adipose-derived stem cells (ADSCs) isolated from renal adipose capsules proliferate faster and in greater numbers compared to those from groin adipose tissues, suggesting they are a more effective source for potential kidney disease treatments.

The study found that renal ADSCs have a lower expression of CD44 compared to groin ADSCs, indicating distinct biological characteristics that may influence their therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study on the biological characteristics of adipose stem cells derived from renal adipose capsule cultured in vitro]. Wu, W., Zheng, HG., Zhang, DW., et al.[2010]

A single intravenous infusion of adipose-derived mesenchymal stem cells (Ad-MSCs) significantly improved kidney structure and function in mice with acute kidney injury induced by cisplatin, leading to better survival rates.

The treatment resulted in reduced inflammation and fibrosis, as indicated by decreased levels of inflammatory markers (TNF-α and TGF-β1) and improved kidney tissue morphology, demonstrating the potential of Ad-MSCs as a therapeutic strategy for kidney regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Renal Parenchyma in Response to Allogeneic Adipose-Derived Mesenchymal Stem Cells Transplantation in Acute Kidney Injury. Begum, S., Ahmed, N., Mubarak, M., et al.[2022]

Adipose-derived mesenchymal stem cells (AD-MSC) significantly protect against kidney injury caused by 45 minutes of renal ischemia followed by 48 hours of reperfusion in rats, as evidenced by improved serum creatinine and blood urea nitrogen levels.

Histological analysis revealed that AD-MSC treatment reduced tubular necrosis and other signs of kidney damage, indicating their potential as a therapeutic intervention for acute kidney injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of adipose-derived mesenchymal stem cells on renal function and histopathology in a rat model of ischemia-reperfusion induced acute kidney injury. Changizi-Ashtiyani, S., Hafazeh, L., Ghasemi, F., et al.[2022]

In a dose escalation study involving 21 subjects, adipose-derived human mesenchymal stem cell (MSC) therapy showed no significant cellular or renal toxicity, indicating a favorable safety profile.

The therapy led to improvements in renal oxygenation and glomerular filtration rate, along with a reduction in inflammatory markers, suggesting potential efficacy in treating renovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving human kidney function in renovascular disease with mesenchymal stem cell therapy. Sivanathan, KN., Coates, PT.[2020]

Transplanting adipose-derived mesenchymal stem cell (ASC) sheets directly into the kidneys of diabetic nephropathy (DN) rats resulted in better therapeutic outcomes compared to intravenous administration, as indicated by lower levels of albuminuria and urinary tumor necrosis factor-α.

The ASC sheets remained viable for 14 days post-transplantation and helped maintain renal structure, suggesting that this method enhances engraftment and could be a promising treatment for DN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transplantation of adipose-derived mesenchymal stem cell sheets directly into the kidney suppresses the progression of renal injury in a diabetic nephropathy rat model. Takemura, S., Shimizu, T., Oka, M., et al.[2022]

In a study involving male Wistar rats with chronic kidney injury induced by adenine, treatment with human adipose tissue-derived stem cells (hADSCs) significantly reduced kidney fibrosis and improved kidney function as indicated by lower serum and urine levels of urea and creatinine.

The hADSC therapy also decreased the expression of several fibrotic and inflammatory markers in the kidneys, suggesting a mechanism by which these stem cells promote kidney repair and reduce damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human adipose derived stem cells regress fibrosis in a chronic renal fibrotic model induced by adenine. Rivera-Valdés, JJ., García-Bañuelos, J., Salazar-Montes, A., et al.[2018]

Adipose tissue-derived stem cells (ASCs) significantly reduce kidney dysfunction and fibrosis when administered shortly after renal injury, as shown in a mouse model where ASCs improved kidney size and reduced collagen deposition within 24 hours of treatment.

Even when administered 6 weeks after injury, ASCs still improved kidney function and reduced fibrosis, indicating their potential for therapeutic use in established kidney damage by modulating inflammation and reducing hypoxia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adipose tissue-derived stem cell treatment prevents renal disease progression. Donizetti-Oliveira, C., Semedo, P., Burgos-Silva, M., et al.[2016]

In a rat model of chronic kidney disease (CKD), adipose tissue-derived mesenchymal stem cells (AD-MSCs) significantly reduced plasma creatinine levels and markers of kidney damage, indicating improved renal function.

AD-MSCs also enhanced the expression of proteins associated with kidney regeneration, such as Pax-2, BMP-7, and VEGF, suggesting their potential as a therapeutic option for CKD due to their availability and less invasive collection method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human mesenchymal stem cells derived from adipose tissue reduce functional and tissue damage in a rat model of chronic renal failure. Villanueva, S., Carreño, JE., Salazar, L., et al.[2022]

The phase I clinical trial involving 12 chronic kidney disease (CKD) patients showed that a single intravenous dose of allogeneic adipose tissue-derived stem cells (ADSCs) was well tolerated, with only minor treatment-related adverse events reported, indicating a favorable safety profile.

Preliminary efficacy results revealed that 58% of participants experienced an increase in their kidney function (eGFR) by Week 24, suggesting that ADSCs may have potential benefits for improving kidney function in CKD patients, although no significant reduction in proteinuria was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic adipose tissue-derived stem cells ELIXCYTE® in chronic kidney disease: A phase I study assessing safety and clinical feasibility. Zheng, CM., Chiu, IJ., Chen, YW., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3445292/

Adipose tissue-derived mesenchymal stem cells Demonstration that phenotype and immunosuppressive ability of adipose tissue-derived mesenchymal stem cells (AD-MSC) are not affected by human kidney disease ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0085253815556275

Adipose tissue–derived mesenchymal stem cells Demonstration that the phenotype and immunosuppressive ability of adipose tissue–derived MSCs are not affected by human kidney disease or uremic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03321942

Treatment of Chronic Renal Failure With Adipose Tissue ... To investigate the biological characteristics of adipose tissue-derived mesenchymal stem cells(AMSCs) and its treatment effects on chronic renal failure.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6577210/

Adipose tissue-derived mesenchymal stromal cells for ... Findings from this pilot study demonstrate that intravenous infusion of autologous expanded AT-MSCs into CKD patients was not associated with adverse effects.

5. kidney-international.org kidney-international.org/article/S0085-2538(15)55627-5/pdf

Adipose tissue–derived mesenchymal stem cells Mesenchymal stem cells are renotropic, helping to repair the kidney and improve function in acute renal failure . ... kidney disease leading to end-stage renal.

6. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/1479-5876-9-51

Adipose-Derived Mesenchymal Stem Cell Protects Kidneys ... Conclusion. ADMSC therapy minimized kidney damage after IR injury through suppressing oxidative stress and inflammatory response. Background. N ...