Stem Cell Therapy to Improve Burn Wound Healing

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of Miami
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Dr. E.Badiavas, University of Miami
ClinicalTrials.gov Identifier:
NCT02104713
First received: April 1, 2014
Last updated: June 24, 2016
Last verified: June 2016
  Purpose

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.


Condition Intervention Phase
Skin Burn Degree Second
Biological: Allogeneic (MSC's) Application to the Burn Wounds
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Pilot Safety Study of the Administration of Mesenchymal Stem Cells (MSC) in the Treatment of Burn Wounds

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Monitoring for adverse events as Assessed by CTCAE v4.0 following administration of allogeneic MSCs to 2nd degree burn wounds. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: April 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allogeneic (MSC's) Application to the Burn Wounds

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

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.

Other Name: Stem Cells Application to the Burn Wounds

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104713

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Olga Orozco, CCRC    305-585-8160    oorozco@med.miami.edu   
Principal Investigator: Carl I. Schulman, MD,PhD,MSPH,FACS         
Sub-Investigator: Louis R. Pizano, MD,MBA,FACS         
Sub-Investigator: Evangelos V. Badiavas, MD, PhD         
Sub-Investigator: Nicholas Namias, MD,MBA,FACS,FCCM         
Sponsors and Collaborators
Dr. E.Badiavas
United States Department of Defense
Investigators
Principal Investigator: Carl Schulman, MD, PhD University of Miami
  More Information

Responsible Party: Dr. E.Badiavas, Associate Professor of Dermatology & Cutaneous Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT02104713     History of Changes
Other Study ID Numbers: 20120925 
Study First Received: April 1, 2014
Last Updated: June 24, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
Skin Burn Degree Second
Second degree Burn
Burn wound

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2016