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Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy

NCT06373809 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-18

No results posted yet for this study

Summary

This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb. Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose. Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot. Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy. Dose escalation and safety will be documented. Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot.

Conditions

  • Diabetic Foot
  • Diabetic Neuropathies
  • Diabetic Foot Ulcer

Interventions

BIOLOGICAL

Transplantation of Placenta Derived Stem Cells

Subcutaneously administered placental-derived SVF / PDSC cells in foot, ankle, and calf tissues in 20 DFU patients

Sponsors & Collaborators

  • Ministerio de Salud de Nicaragua

    collaborator UNKNOWN

  • Wake Forest Institute for Regenerative Medicine

    collaborator UNKNOWN

  • Michael H Carstens

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2024-03-31
Completion
2024-03-31

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 NCT06373809 on ClinicalTrials.gov