Stem Cell Therapy to Improve Burn Wound Healing

NCT02104713 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 20120925
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Skin Burn Degree Second; Second degree Burn; Burn wound

Outcome Measures

Primary Outcomes (1)

• Monitoring for adverse events as Assessed by CTCAE v4.0 following administration of allogeneic MSCs to 2nd degree burn wounds.

  The study will consist of a dose escalation phase consisting of four dose levels. Each dose level will compare the safety of administering allogeneic MSCs, with 5 patients per group.

  1.5 years

Study Arms (1)

Allogeneic (MSC's) Application to the Burn Wounds

EXPERIMENTAL

Allogeneic (MSC's) Application to the Burn Wounds. The 1st group of 5 will be started on the lowest dose. If there are no adverse reactions, the 2nd group of 5 will receive a higher dose. This will be repeated for the 3rd and 4th groups with each receiving a higher dose. Up to 2 administrations of cells 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.

Biological: Allogeneic (MSC's) Application to the Burn Wounds

Interventions

Allogeneic (MSC's) Application to the Burn Wounds BIOLOGICAL

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.

Also known as: Stem Cells Application to the Burn Wounds

Allogeneic (MSC's) Application to the Burn Wounds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 18 years of age or older with Superficial, Intermediate or Deep 2nd Degree Burn Wounds
• Injury within the prior 7 days
• Subjects must understand and give written informed consent.
• Subjects must agree to have biopsies performed as per protocol
• Subjects must be accessible for weekly wound treatment and assessment visits
• Males and females must agree to use an acceptable method of contraception. Exceptions will be females of non-childbearing age and monogamous males who are partners of females of non-childbearing age. Acceptable methods of birth control include; history of sterilization, birth control pills, depoprogesterone injections, a barrier contraceptive such as a condom with or without spermicide cream or gel, diaphragms or cervical cap with or without spermicide cream or gel, or an intrauterine device (IUD).
• Maximum wound size limited to:
• Single wound: ≤ 5% body surface area (BSA)
• Multiple wounds treated in a defined anatomical region with ≤ 20% cumulative BSA.
• Diabetic subjects: HbA1c ≤ 8%

You may not qualify if:

• Solely 1st degree or solely 3rd degree burns
• Subjects with superficial 2nd degree burn who are expected to heal within 2 weeks post standard therapy
• Evidence of active infection at the wound site
• Evidence of significant wound healing prior to treatment
• Wound located in the area of fingers, toes, face, or perineum
• Wound where 75% or more extends across joints
• Electrical or chemical burns
• Have any requirement for the use of systemic steroids or immunosuppressive
• Subjects Allergic to human albumin, streptomycin, or penicillin
• Be a pregnant female or nursing mother
• Subjects who are known or found to be HIV positive
• Current history of alcohol or substance abuse or history of alcohol or substance abuse requiring treatment within the past 12 months
• Patients with severe medical conditions
• Malignancy (other than non melanoma skin cancer) not in remission or in remission less than 5 years
• Life expectancy less than two years

Sponsors & Collaborators

• E.Badiavas: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Maranda EL, Wang MX, Shareef S, Tompkins BA, Emerson C, Badiavas EV. Surgical management of leukoderma after burn: A review. Burns. 2018 Mar;44(2):256-262. doi: 10.1016/j.burns.2017.05.004. Epub 2017 Jun 8.

  PMID: 28602587 DERIVED

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Carl Schulman, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Dermatology & Cutaneous Surgery

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: June 4, 2014
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)