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Stem Cell Therapy to Improve Burn Wound Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104713
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
E.Badiavas, University of Miami

Tracking Information
First Submitted Date  ICMJE April 1, 2014
First Posted Date  ICMJE April 4, 2014
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE June 4, 2014
Actual Primary Completion Date March 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2014)
Reduction of number of Adverse Events [ Time Frame: 1.5 years ]
Reduction of number of Adverse Events like blistering, inflammation and rash per participant
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Therapy to Improve Burn Wound Healing
Official Title  ICMJE A Pilot Safety Study of the Administration of Mesenchymal Stem Cells (MSC) in the Treatment of Burn Wounds
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Skin Burn Degree Second
Intervention  ICMJE 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
Study Arms  ICMJE 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.

Intervention: Biological: Allogeneic (MSC's) Application to the Burn Wounds
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2020)
15
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2014)
20
Actual Study Completion Date  ICMJE March 18, 2019
Actual Primary Completion Date March 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

- 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02104713
Other Study ID Numbers  ICMJE 20120925
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party E.Badiavas, University of Miami
Study Sponsor  ICMJE E.Badiavas
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Carl Schulman, MD, PhD University of Miami
PRS Account University of Miami
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP