Skin Burn Degree SecondPhase 1NCT02104713
Stem Cell Therapy to Improve Burn Wound Healing
A Phase 1 study testing Allogeneic (MSC's) Application to the Burn Wounds in people with Skin Burn Degree Second, run by E.Badiavas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Burn Degree Second
- What is being tested?
- Allogeneic (MSC's) Application to the Burn Wounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2014to 18 Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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%
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Safety Study of the Administration of Mesenchymal Stem Cells (MSC) in the Treatment of Burn Wounds
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.
- Conditions
- Skin Burn Degree Second
- Being tested
- Allogeneic (MSC's) Application to the Burn Wounds
- Keywords
- Skin Burn Degree Second, Second degree Burn, Burn wound
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic (MSC's) Application to the Burn WoundsBiological
Also called Stem Cells 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
- Initial dose level will be 2.5 x 10³ Allogeneic MSCs cells/square cm.
- Second dose level 5 X 10³ Allogeneic MSCs cells/square cm.
- Third dose level 1 X 10⁴ Allogeneic MSCs cells/square cm.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic (MSC's) Application to the Burn Wounds | Experimental | 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. Receives: Biological: Allogeneic (MSC's) Application to the Burn Wounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring for adverse events as Assessed by CTCAE v4.0 following administration of allogeneic MSCs to 2nd degree burn wounds.
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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study start4 Jun 2014
- Primary completion18 Mar 2019
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Burn Degree SecondStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- E.Badiavas
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, E.Badiavas, University of Miami
- Investigators
- Carl Schulman, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104713
- Sponsor's protocol ID
- 20120925
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2014
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28602587
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Safety Study of the Administration of Mesenchymal Stem Cells (MSC) in the Treatment of Burn Wounds
- ClinicalTrials.gov ID
- NCT02104713
- Acronym / sponsor ID
- 20120925
- Conditions
- Skin Burn Degree Second
- Keywords
- Skin Burn Degree Second, Second degree Burn, Burn wound
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- E.BadiavasUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 4 Jun 2014 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic (MSC's) Application to the Burn Wounds | Experimental | Biological: Allogeneic (MSC's) Application to the Burn WoundsAllogeneic (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic (MSC's) Application to the Burn WoundsAlso: Stem Cells Application to the Burn WoundsAllogeneic (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. | Biological | Allogeneic (MSC's) Application to the Burn Wounds |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Derived from this study: PubMed 28602587Maranda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Schulman, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic (MSC's) Application to the Burn Wounds in people with Skin Burn Degree Second, run by E.Badiavas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02104713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.