Stem Cell Therapy for Pressure Ulcers

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: Steroids, Chemotherapy

Disqualifiers: Poor glucose control, Cancer, others

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

Compensation: Varies

Number of Visits: 8

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using stem cells from a person's own fat to heal serious wounds, such as deep pressure sores or diabetic foot ulcers. The goal is to determine if this method is safe and improves wound healing. Participants will have a small amount of fat removed, and the stem cells (adipose-derived stromal cells) will be applied to their wound. Individuals with medium to large pressure ulcers or diabetic foot ulcers, who can attend weekly follow-ups, might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude patients on prolonged steroid use, active chemotherapy, or radiation near the wound, which might suggest some medication restrictions.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using fat-derived cells, known as adipose-derived stromal cells (ASCs), is generally safe for treating wounds such as pressure sores. In some studies, 71% of patients in France and 66% in South Korea experienced improved healing with this treatment. Another review found benefits like better wound healing and reduced inflammation. These results suggest that ASCs are well-tolerated and may help wounds heal more effectively.

Although this trial is in its early stages, these cells have been used safely in the past and have shown promise in other studies, indicating their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for pressure ulcers, which often involve wound dressings, debridement, and sometimes skin grafts, stem cell therapy using adipose-derived stromal cells (ASCs) offers a novel approach. Researchers are excited because ASCs can potentially regenerate damaged tissue, thanks to their ability to differentiate and promote healing at the cellular level. Additionally, the use of a fibrin sealant applicator allows for precise application of these cells directly to the wound, potentially enhancing the healing process more effectively than traditional methods. This innovative therapy could shorten healing times and improve outcomes for patients with pressure ulcers.

What evidence suggests that adipose-derived stromal cells might be an effective treatment for pressure ulcers?

Research has shown that certain cells from body fat, called adipose-derived stromal cells (ASCs), can heal wounds like pressure sores more effectively. In this trial, participants will receive ASCs applied directly to their wounds. Studies have found that these cells speed up the healing process by aiding skin regeneration. In animal tests, both fresh and stored ASCs helped wounds heal faster than those without these cells. Other research has demonstrated that ASCs can reduce swelling and improve tissue repair. These promising findings suggest that ASCs could effectively treat serious wounds in humans. ^{2 3 5 6 7}

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 individuals with Stage III pressure ulcers or diabetic foot ulcers. Participants can be male or female, inpatient or outpatient, and must be able to consent and return for weekly assessments. They should not have poorly controlled diabetes, severe peripheral vascular disease, recent radiation near the wound, need for certain therapies like NPWT, extreme low body weight (BMI <16), critical colonization/infection of wounds, prolonged steroid use, liver disease complications, facial wounds, allergies to specific medical products used in the study.

Inclusion Criteria

I am receiving treatment for bedsores.

I have conditions like heart disease, kidney or liver issues, high blood pressure, or diabetes.

I can give consent or have someone who can consent for me.

Exclusion Criteria

You are allergic to TISSEEL, Tegaderm, or silicon.

My BMI is less than 16 and I show signs of a severe infection.

I have been using steroids for more than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Liposuction and Cell Processing

Liposuction is performed to extract adipose tissue, which is processed to obtain stromal cells for treatment

1 week

1 visit (in-person)

Treatment

Adipose-derived stromal cells are injected into a fibrin sealant and applied to the wound

1 week

1 visit (in-person)

Follow-up

Participants are monitored weekly for wound healing and treatment tolerance

6 weeks

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Adipose-derived stromal cells

Trial Overview The trial tests applying autologous adipose-derived stromal cells (ASCs) on serious pressure sores or diabetic foot ulcers. Patients undergo a minor liposuction to extract stem cell-containing tissue from their own fat. These cells are then applied using a fibrin sealant directly onto the wound. The main goal is to see if this treatment helps heal the wound over six weeks.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Liposuction will be done to extract 50-100 cc of adipose tissue which will be processed to obtain the stromal cells. The adipose-derived stromal cells will be injected into a fibrin sealant applicator and applied to the wound (intervention), Patients will receive 5.0x106 ASCs per cubic centimeter of wound area. The wound will be dressed with an occlusive dressing and soft silicone dressing. The dressing will remain in place for one week (minimally, 3 days). Follow-up will occur weekly for 6 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

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]

A systematic review of 70 studies involving over 1,400 patients treated with adipose-derived cell therapy indicated a generally favorable safety profile, with only one reported case of breast cancer recurrence among 121 patients.

Concerns remain regarding thromboembolic events, as one case of pulmonary thromboembolism and instances of myocardial and cerebral infarctions were noted, highlighting the need for improved safety assessment methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concise Review: A Safety Assessment of Adipose-Derived Cell Therapy in Clinical Trials: A Systematic Review of Reported Adverse Events. Toyserkani, NM., Jørgensen, MG., Tabatabaeifar, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4449094/

Adipose Stromal Cells Repair Pressure Ulcers in Both ... ASCs enhance wound healing rates through adipogenic differentiation and regeneration of the underlying architecture of the skin.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02375802

Adipose-Derived Stromal Cells (ASC's) for Pressure Ulcers This pilot study of 12 patients will test the safety and efficacy of applying autologous, adipose-derived stromal cells (ASCs), uncultured, on a Stage III ...

3. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-024-01523-5

Therapeutic potential of adipose-derived stem cells for ... The primary outcomes we targeted included healing rate, healing time, and the total number of healed ulcers at the end of follow-up duration and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10743704/

Mesenchymal Stromal Cell Healing Outcomes in Clinical ... All studies reported positive results, including improved wound healing, reduced inflammation, and improved tissue regeneration.

5. liebertpub.com liebertpub.com/doi/10.1089/scd.2019.0244?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

Safety and Efficacy of Human Adipose-Derived Stromal ... Both fresh and cryopreserved human ASCs significantly accelerated and enhanced wound healing in young (2 month) mice of both sexes relative to DFC controls ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7153639/

Safety and Efficacy of Human Adipose-Derived Stromal ... The PUs displayed quantitative evidence of healing in 71% (France) and 66% (South Korea) of the afflicted patients [43,44]. While the mechanism of action for ...

7. mdpi.com mdpi.com/2077-0383/12/24/7545

Mesenchymal Stromal Cell Healing Outcomes in Clinical ... All studies reported positive results, including improved wound healing, reduced inflammation, and improved tissue regeneration.