Clinical trial NCT02104713: Stem Cell Therapy to Improve Burn Wound Healing
Official title: A Pilot Safety Study of the Administration of Mesenchymal Stem Cells (MSC) in the Treatment of Burn Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Burn Degree Second
Keywords: Skin Burn Degree Second
Second degree Burn
Burn wound
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2014-04-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: - Donors:

Eligibility Criteria:

* No history of malignancy
* No active coagulopathy and/or hypocoagulable state
* No history of cardio/pulmonary conditions
* Negative tests for Hepatitis A, Hepatitis B, Hepatitis C, RPR, HIV 1 / 2, HTLV I/II, Chagas Disease, NAT for HCV, HIV and WNV.
* Hemoglobin ≥ 13.0 g/dL
* Platelet count 140,000 to 440,000/ul
* WBC 3.0 to 11.0 K/ul
* BNP ≤ 100 pg /mL
* No anomalies on the CBC and differential suggestive of a hematopoietic disorder
* Creatinine ≤ 1.5 mg/dL
* ALT ≤ 112 IU/L
* AST ≤ 100 IU/L
* Bilirubin \< 1.5 mg/dL
* No diabetes
* Systolic blood pressure ≤ 170
* Diastolic blood pressure ≤ 90
* No history of autoimmune disorders

Recipients:

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

Primary outcomes:
measure: Monitoring for adverse events as Assessed by CTCAE v4.0 following administration of allogeneic MSCs to 2nd degree burn wounds.
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Carl Schulman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.