Stem Cell Therapy to Improve Burn Wound Healing

Phase 1

Completed

• Conditions: Skin Burn Degree Second

• Registration Number: NCT02104713
• Lead Sponsor: E.Badiavas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Study Start: 2014-06-04
• Primary Completion: 2019-03-18
• Study Completion: 2019-03-18
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Male or female subjects 18 years of age or older with Superficial, Intermediate or Deep 2nd Degree Burn Wounds

2. Injury within the prior 7 days

3. Subjects must understand and give written informed consent.

4. Subjects must agree to have biopsies performed as per protocol

5. Subjects must be accessible for weekly wound treatment and assessment visits

6. 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).

7. Maximum wound size limited to:

   • Single wound: ≤ 5% body surface area (BSA)
   • Multiple wounds treated in a defined anatomical region with ≤ 20% cumulative BSA.

8. Diabetic subjects: HbA1c ≤ 8%

Exclusion Criteria

1. Solely 1st degree or solely 3rd degree burns

2. Subjects with superficial 2nd degree burn who are expected to heal within 2 weeks post standard therapy

3. Evidence of active infection at the wound site

4. Evidence of significant wound healing prior to treatment

5. Wound located in the area of fingers, toes, face, or perineum

6. Wound where 75% or more extends across joints

7. Electrical or chemical burns

8. Have any requirement for the use of systemic steroids or immunosuppressive

9. Subjects Allergic to human albumin, streptomycin, or penicillin

10. Be a pregnant female or nursing mother

11. Subjects who are known or found to be HIV positive

12. Current history of alcohol or substance abuse or history of alcohol or substance abuse requiring treatment within the past 12 months

13. Patients with severe medical conditions

    1. Malignancy (other than non melanoma skin cancer) not in remission or in remission less than 5 years
    2. Life expectancy less than two years
    3. Severe cardiopulmonary disease restricting ambulation to the clinical facility

14. 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.

15. Subjects with abnormal bilirubin levels.

16. Subjects with abnormal PT/INR laboratory values while not on chronic anticoagulant treatment which can be held for minor surgical procedures

17. Those with a known history of coagulopathy

18. Subjects who are potential recipients of tissue or organ transplantation

19. Subjects with circulating Hepatitis B antigen and/or who are seropositive for Hepatitis C antibody

20. History of poor compliance, unreliability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Monitoring for adverse events as Assessed by CTCAE v4.0 following administration of allogeneic MSCs to 2nd degree burn wounds.	1.5 years	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States