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Stromal Vascular Cells for the Treatment of Diabetic Peripheral Neuropathy

NCT07553468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-04-28

No results posted yet for this study

Summary

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

Conditions

  • Diabetic Foot
  • Diabetic Peripheral Neuropathy

Interventions

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.

Sponsors & Collaborators

  • Michael H Carstens

    lead OTHER

Principal Investigators

  • Kenneth A Bertram, MD, PhD · Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USA

  • Michael H Carstens, MD · Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-02-28
Completion
2026-03-31

Countries

  • Nicaragua

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553468 on ClinicalTrials.gov