Stromal Vascular Cells for the Treatment of Diabetic Peripheral Neuropathy (SVFDPN)

April 22, 2026 updated by: Michael H Carstens

Treatment of Diabetic Peripheral Neuropathy With Adipose-derived Stromal Vascular Fraction Cells

This is an interventional open-label study to determine the safety and clinical performance of SVF cells in the treatment of Diabetic Peripheral Neuropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The burden of diabetes mellitus (DM) is a global socio-economic burdern affecting an estimate 578 million (M) people by 2030 and consuming 10% of world health care expenditures. Sequelae of diabetes are seen in the distal extremities, the most common being peripheral neuropathy (DPN) affecting up to 50% of patients within the first 10 years of the disease. Painful neuropathy is present in 20-30% of patients and is resistant to pharmaceutical treatments such as tricyclics antidepressants, anticonvulsants, serotonin reuptake inhibitors, and opioids. No FDA-approved therapies with disease-modifying activity currently exist. In over 50% of patients DPN follows a progressive course characterized initially by loss of pedal sensation, predisposing to failure to perceive traumatic injuries with consequent ulceration and the threat of limb loss.

Several types of adult derived mesenchymal sromal/stem (sic) cells have been used for the treatment of DFUs with varied results based on their anti-inflammatory, anti-fibrotic and tissue repair properties. Adipose tissue provides a readily accessible sources of MSCs; these cells can be isolated from the adipose structural components after liposuction and subsequently cultured. Drawbacks of AD-MSCs include the cost of Good Manufacturing Practice culure/manufacturing, time of manufacturing and potential allergic reactions, if the cell prduct comes from an allogeneic source. An alternative to cultured/manufactured AD-MSC is an AD-MSC containing product, stromal vascular fraction (SVF), that can be obtained and delivered as a point-of-care intervention.

SVF has been shown to secrete numerous growth factors and cytokines, including vascular endothelial growth factor, transforming growth factor-1 and hepatocyte growth factor, and interferon-gamma and IL-10. In addition, SVF has been shown to induce M2 macrophages, further driving an anti-inflammatory environment. SVF has been used in multiple clinical trials to treat diabetic foot ulcers, peripheral vascular disease, burn wounds, radiation injury and Crohn's disease fistula, among other disease states. SVF has been used in the United States under a Food and Drug Administration investigational device exemption to treat knee osteoarthritis (safe and with evidence of potential efficacy) and is currently in a pivotal clinical trial ("150 subjects) for that indication.

In previous publications regarding treatment of chronic wounds due to diabetes and ischemia anecdotal evidence of long-term improvements in sensation were noted. For this reason this additional study was designed to investigate the clinical of using SVF cells for the treatment of DPN.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nicaragua
    • León Department
      • León, León Department, Nicaragua, 21000
        • Hospital Escuela Oscar Danilo Rosales Argüello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinically stable diabetes
  • Presence of DPN as documented reductions in sensory perception threshold (SPT) and/or vibration perception threshold below protective levels
  • Capacity to understand and provide informed consent.

Exclusion Criteria:

  • Presence of a disease prohibitive of surgical intervention
  • Smoking and/or substance abuse within 3 months of the onset of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Foot ulcer and leg neuropathy
The intervention at the foot being carried out by administrating a standardized dose of 50 million SVF cells suspended in Lactated Ringer's (LR) solution for a total volume of 60cc.
Biological: Adipose-derived Stromal Vascular Fraction Cells

Administration to the DFU / ankle was performed at four injection sites:

  1. 20 cc into the wound bed
  2. 20 cc subcutaneously around the perimeter of the wound
  3. 10 cc along the tibialis posterior pathway at the ankle prior to entry into the plantar surface
  4. 10 cc along the tibialis anterior / dorsalis pedis pathway from the ankle to the dorsum of the foot.
Other Names:
  • SVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot Ulcer Healing
Time Frame: Baseline, 4, 12, 24, and 48 weeks post treatment.
Percent closure based on changes in ulcer size dimensions in square cm.
Baseline, 4, 12, 24, and 48 weeks post treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes
Time Frame: Baseline, 4, 12, 24, and 48 weeks post treatment.
Semmes-Weinstein scores to document sensation threshold
Baseline, 4, 12, 24, and 48 weeks post treatment.
Vibration: Documenting diabetes-associated lower extremity pathophysiology changes
Time Frame: Baseline, 4, 12, 24, and 48 weeks post treatment.
Horwell neurothesiometer scores to document vibration threshold
Baseline, 4, 12, 24, and 48 weeks post treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael H Carstens

Investigators

  • Study Director: Kenneth A Bertram, MD, PhD, Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USA
  • Principal Investigator: Michael H Carstens, MD, Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DVS-DSG-CJST-0205-12-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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