Stromal Vascular Cells for the Treatment of Diabetic Peripheral Neuropathy

NCT07553468 | Completed

• 1 other identifier: DVS-DSG-CJST-0205-12-2025
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Foot Ulcer Healing

  Percent closure based on changes in ulcer size dimensions in square cm.

  Baseline, 4, 12, 24, and 48 weeks post treatment.

Secondary Outcomes (2)

• Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes

  Baseline, 4, 12, 24, and 48 weeks post treatment.

• Vibration: Documenting diabetes-associated lower extremity pathophysiology changes

  Baseline, 4, 12, 24, and 48 weeks post treatment.

Study Arms (1)

Foot ulcer and leg neuropathy

EXPERIMENTAL

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

Interventions

Adipose-derived Stromal Vascular Fraction Cells BIOLOGICAL

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.

Also known as: SVF

Foot ulcer and leg neuropathy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Michael H Carstens: lead

Study Sites (1)

Hospital Escuela Oscar Danilo Rosales Argüello

León, León Department, 21000, Nicaragua

Location

Related Publications (5)

• Amos PJ, Shang H, Bailey AM, Taylor A, Katz AJ, Peirce SM. IFATS collection: The role of human adipose-derived stromal cells in inflammatory microvascular remodeling and evidence of a perivascular phenotype. Stem Cells. 2008 Oct;26(10):2682-90. doi: 10.1634/stemcells.2008-0030. Epub 2008 Apr 24.

  PMID: 18436860 BACKGROUND

• Bourin P, Bunnell BA, Casteilla L, Dominici M, Katz AJ, March KL, Redl H, Rubin JP, Yoshimura K, Gimble JM. Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells: a joint statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT). Cytotherapy. 2013 Jun;15(6):641-8. doi: 10.1016/j.jcyt.2013.02.006. Epub 2013 Apr 6.

  PMID: 23570660 BACKGROUND

• Bura A, Planat-Benard V, Bourin P, Silvestre JS, Gross F, Grolleau JL, Saint-Lebese B, Peyrafitte JA, Fleury S, Gadelorge M, Taurand M, Dupuis-Coronas S, Leobon B, Casteilla L. Phase I trial: the use of autologous cultured adipose-derived stroma/stem cells to treat patients with non-revascularizable critical limb ischemia. Cytotherapy. 2014 Feb;16(2):245-57. doi: 10.1016/j.jcyt.2013.11.011.

  PMID: 24438903 BACKGROUND

• Carstens MH, Gomez A, Cortes R, Turner E, Perez C, Ocon M, Correa D. Non-reconstructable peripheral vascular disease of the lower extremity in ten patients treated with adipose-derived stromal vascular fraction cells. Stem Cell Res. 2017 Jan;18:14-21. doi: 10.1016/j.scr.2016.12.001. Epub 2016 Dec 8.

  PMID: 27984756 BACKGROUND

• Carstens MH, Mendieta M, Perez C, Villareal E, Garcia R. Assisted Salvage of Ischemic Fasciocutaneous Flap Using Adipose-Derived Mesenchymal Stem Cells: In-Situ Revascularization. Aesthet Surg J. 2017 Jul 1;37(suppl_3):S38-S45. doi: 10.1093/asj/sjx052.

  PMID: 29025216 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Kenneth A Bertram, MD, PhD

  Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USA

  STUDY DIRECTOR

• Michael H Carstens, MD

  Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 28, 2026
• Study Start: December 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: March 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

NI (1)