Stem Cell Therapy to Improve Burn Wound Healing

Completed · Phase 1

Conditions studied: Skin Burn Degree Second

In brief

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.

Key facts

Study ID

NCT02104713

Run by

E.Badiavas

People needed

15

Starts

2014-06-04

Expected to finish

2019-03-18

Last updated by the study team

2020-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• Severe cardiopulmonary disease restricting ambulation to the clinical facility
• WBC <3 or > 10 x10⁹/L, Hgb < 9g/dL, platelets count 100x10⁹/L or less, serum creatinine > 1.5 times the upper normal limit, AST or ALT > 2.5 times the upper normal limit.
• Subjects with abnormal bilirubin levels.
• Subjects with abnormal PT/INR laboratory values while not on chronic anticoagulant treatment which can be held for minor surgical procedures
• Those with a known history of coagulopathy
• Subjects who are potential recipients of tissue or organ transplantation
• Subjects with circulating Hepatitis B antigen and/or who are seropositive for Hepatitis C antibody
• History of poor compliance, unreliability

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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