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Stem Cell Therapy to Improve Burn Wound Healing

NCT02104713 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-04-30

No results posted yet for this study

Summary

This study will determine the safety of allogeneic stem cell therapy from healthy donors, for 2nd degree burn wounds of less than 20% Total Body Surface Area (TBSA), at four different dose levels.

Clinical evaluation will take place every 1 to 4 weeks intervals until wound closure, and then monthly for 6 months following the last administration of MSCs.

Once the safety and dose-response analysis in Phase 1 is completed, an expanded trial will be initiated to better examine the efficacy of MSC therapy in 2nd degree burn wounds. Phase 1 will establish the maximum safe dose that will be used in the Phase II trial.

Conditions

  • Skin Burn Degree Second

Interventions

BIOLOGICAL

Allogeneic (MSC's) Application to the Burn Wounds

Allogeneic (MSC's) Application to the Burn Wounds. The first group of 5 will be started on the lowest dose. If there are no adverse reactions, the second group of 5 will receive a higher dose. This will be repeated for the third and fourth groups with each receiving a higher dose 1. Initial dose level will be 2.5 x 10³ Allogeneic MSCs cells/square cm. 2. Second dose level 5 X 10³ Allogeneic MSCs cells/square cm. 3. Third dose level 1 X 10⁴ Allogeneic MSCs cells/square cm. 4. Fourth dose level 2 X 10⁴ Allogeneic MSCs cells/square cm. Up to 2 administrations of cells will be allowed per dose level to be given over a period of no more than 8 weeks. Each administration of cells will be no less than ten days apart and no more than 6 weeks apart.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • E.Badiavas

    lead OTHER

Principal Investigators

  • Carl Schulman, MD, PhD · University of Miami

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-04
Primary Completion
2019-03-18
Completion
2019-03-18
FDA Drug
Yes

Countries

  • United States

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 NCT02104713 on ClinicalTrials.gov