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)

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 fistula failure when applied during the time of surgical creation.

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 the use of autologous adipose-derived mesenchymal stem cells (AMSCs) safe for humans?

Studies have shown that autologous adipose-derived mesenchymal stem cells (AMSCs) are generally safe for use in humans, with no serious adverse events reported in various clinical applications, including arthritis and complex perianal fistulas. Preclinical studies in animals also support their safety, showing no harmful effects on joint tissues. ^{1 2 3 4 5}

How is the treatment with autologous adipose-derived mesenchymal stem cells (AMSC) for fistula in hemodialysis patients different from other treatments?

This treatment is unique because it uses the patient's own fat-derived stem cells, which are injected directly into the area around the fistula to promote healing and prevent complications, unlike other treatments that may not use stem cells or target the fistula in this way. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) for fistulas in hemodialysis patients?

Research shows that adipose-derived stem cells have been effective in treating complex perianal fistulas, suggesting potential benefits for similar conditions. These stem cells have been used successfully in other trials to promote healing in fistula cases, indicating they might help in hemodialysis patients as well. ^{3 6 7 9 10}

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. United States pubmed.ncbi.nlm.nih.gov

Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Autologous adipose tissue-derived stem cells for the treatment of complex perianal fistulas not associated with Crohn's disease: a phase II clinical trial for safety and efficacy. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up of Crohn Disease Fistulas After Local Injections of Bone Marrow-Derived Mesenchymal Stem Cells. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Treatment of Complex Idiopathic Fistula-in-Ano Using Autologous Centrifuged Adipose Tissue Containing Progenitor Cells: A Randomized Controlled Trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Rationale and Trial Design of MesEnchymal Stem Cell Trial in Preventing Venous Stenosis of Hemodialysis Vascular Access Arteriovenous Fistula (MEST AVF Trial). [2023]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Administration of Autologous Mesenchymal Cells for the Treatment of Arthritis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Safety Studies for Use of Adipose Tissue-Derived Mesenchymal Stromal/Stem Cells in a Rabbit Model for Osteoarthritis to Support a Phase I Clinical Trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Human Adipose-Derived Mesenchymal Stem Cells in Cell Therapy: Safety and Feasibility in Different "Hospital Exemption" Clinical Applications. [2022]

10. Iran pubmed.ncbi.nlm.nih.gov

Systemic Infusion of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in Peritoneal Dialysis Patients: Feasibility and Safety. [2022]