AMSC for Fistula in Hemodialysis Patients

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mayo Clinic

Must not be taking: Immunosuppressants, Investigational drugs

Disqualifiers: Malignancy, Immunodeficiency, Hypercoagulable, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate (during surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a type of stem cell treatment, using cells from a patient's own fat tissue, might improve the function of dialysis fistulas (surgical connections for blood flow). It examines different methods of administering this treatment during surgeries for dialysis connections. Individuals currently on, or about to start, hemodialysis who need a fistula in their arm might be suitable candidates. The trial aims to determine if the treatment can prevent fistula failure, thereby making dialysis smoother for patients. As a Phase 1/Phase 2 trial, it focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking investigational drugs or have certain conditions, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that stem cells taken from a patient's own fat are being tested for safety in people with severe kidney disease. Earlier studies found that these stem cells are usually well-tolerated, with most patients not experiencing serious side effects. Some reported minor issues, such as mild discomfort at the injection site. As this trial is in the early stages, the main goal is to ensure the treatment's safety for humans, so participants will be closely monitored for any problems. Using stem cells from the patient's own fat generally reduces the risk of serious reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about using Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) for treating fistulas in hemodialysis patients because these stem cells offer a novel approach to healing and regeneration. Unlike the typical surgical or pharmacological options, AMSCs are derived from the patient’s own fat tissue, which reduces the risk of rejection and potential complications. These stem cells have the ability to promote tissue repair and reduce inflammation, which could lead to more efficient and long-lasting solutions for maintaining functional dialysis fistulas. Additionally, the ability to deliver these cells at different stages of fistula development provides flexibility in treatment and could enhance the overall success rate of dialysis access procedures.

What evidence suggests that this trial's treatments could be effective for reducing hemodialysis arteriovenous fistula failure?

Research has shown that using a person's own fat cells, known as autologous adipose-derived mesenchymal stem cells (AMSC), might help prevent problems with arteriovenous fistulas (AVF) used in dialysis. In this trial, participants will receive different AMSC treatments based on their assigned group. Some will receive AMSC treatment at the first and second stages of brachiobasilic arteriovenous fistula, while others will receive a single dose of AMSC in radiocephalic or brachiocephalic arteriovenous fistulas. These special cells, taken from the participant's own fat, could improve the health of blood vessels. Past patients have shown encouraging results, indicating that AMSCs might reduce the risk of fistula issues. While more data is needed to confirm effectiveness, using one's own cells for healing is a promising approach. ^{1 2 3 4 6}

Who Is on the Research Team?

Sanjay Misra, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 on hemodialysis or pre-dialysis needing an upper extremity AV fistula, who can consent and follow the study plan. They should expect to live at least two more years. It's not for sponsor employees, pregnant/breastfeeding individuals, recent investigational drug/device users, cancer patients within six months, those with immune/autoimmune diseases or a history of clotting issues.

Inclusion Criteria

Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures

You are currently receiving hemodialysis or are planning to receive hemodialysis with a specific type of access in your arm.

You are expected to live for at least 2 years.

Exclusion Criteria

Employees of the sponsor or patients who are employees or relatives of the investigator

Pregnancy or breast feeding

Treatment with any investigational drug/ device within 60 days prior to study entry

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) during the surgical creation of arteriovenous fistula

Immediate (during surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Adipose Derived Mesenchymal Stem Cells (AMSC)

Trial Overview The study tests if one or two applications of patient's own fat-derived stem cells (AMSC) can reduce failure rates in newly created arteriovenous fistulas used for hemodialysis compared to a placebo. This phase 1 trial aims to improve vascular access longevity.

How Is the Trial Designed?

Group I: Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula Experimental Treatment 1 Intervention

Subjects who receive a radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC)

Group II: Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula Experimental Treatment 1 Intervention

Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at time of first stage of BBF

Group III: AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula Experimental Treatment 1 Intervention

Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at first and second stage of BBF

Group IV: No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula Active Control 1 Intervention

Patients receive standard of care.

Group V: Placebo treatment in brachiobasilic arteriovenous fistula Placebo Group 1 Intervention

Subjects will receive placebo at first and second stage of BBF

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a phase II clinical trial involving 59 patients with complex perianal fistulas, treatment with adipose-derived stem cells (ASCs) combined with fibrin glue resulted in a significantly higher healing rate (71%) compared to fibrin glue alone (16%), indicating that ASCs enhance treatment efficacy.

The treatment was well tolerated, with a low recurrence rate of 17.6% at one year, and patients receiving ASCs reported better quality of life scores, suggesting that this therapy is both effective and safe for managing complex perianal fistulas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Garcia-Olmo, D., Herreros, D., Pascual, I., et al.[2022]

A review of 2,011 injections of autologous mesenchymal stem cells (AMSCs) for treating arthritis found no specific adverse events, indicating that these injections are completely safe.

The study concluded that AMSCs do not pose an increased risk of complications such as infections or tumor formation compared to traditional arthritis treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of Autologous Mesenchymal Cells for the Treatment of Arthritis. Prodromos, C., Rumschlag, T.[2021]

The study evaluated the safety and efficacy of autologous adipose-derived stem cell (ASC) therapies in 17 patients with severe conditions, finding no serious adverse events over a follow-up period of up to 54 months.

Both ASC-derived products—a scaffold-free osteogenic graft for bone non-union and a biological dressing for chronic wounds—were successfully manufactured and implanted without contamination or genomic issues, demonstrating their feasibility for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. Vériter, S., André, W., Aouassar, N., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02808208

Autologous Adipose Derived Mesenchymal Stem Cells ... The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8986037/

Rationale and Trial Design of MesEnchymal Stem Cell Trial in ... Autologous adipose-derived mesenchymal stem cells may help reduce VS formation associated with hemodialysis AVF. There are no therapies available to prevent VS ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02808208?tab=table

Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35419530/

Rationale and Trial Design of MesEnchymal Stem Cell Trial in ... This is a phase 1/2 single-center, randomized trial that will investigate the safety and efficacy of autologous AMSCs in promoting ...

5. hmpgloballearningnetwork.com hmpgloballearningnetwork.com/site/vdm/content/randomized-clinical-trial-using-autologous-adipose-derived-mesenchymal-stem-cells

Randomized Clinical Trial Using Autologous Adipose-Derived ... The study will evaluate the safety and effectiveness of the Artero™ IVL system in treating peripheral arterial disease (PAD) and support FastWave's ultimate ...

6. journals.lww.com journals.lww.com/kidney360/fulltext/2021/08000/novel_clinical_therapies_and_technologies_in.18.aspx

Novel Clinical Therapies and Technologies in Dialysis... Presently, a clinical trial in patients with AVFs is underway to test the safety and efficacy of autologous stem-cell transplantation for preventing AVF failure ...