Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 18-004995 | Other Identifier | Mayo Clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ProPharma Group | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety of a biological therapeutic PEP in participants who have skin graft donor site wounds.
This is an open label phase 1b study of PEP (a leukocyte depleted blood preparation derived from human U.S. sourced pooled apheresed platelets) in patients with at least two donor split-thickness skin graft wounds. One donor site will be treated with the standard post-operative dressing, while the other site will be treated with PEP or PEP+TISSEEL and covered with a standard dressing. TISSEEL is a commercially available fibrin sealant.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 % PEP only | Experimental | Cohort 1: Subjects will receive 10% PEP to the skin graft donor wound. |
|
| 20% PEP only | Experimental | Cohort 2: Subjects will receive 20% PEP to the skin graft donor wound |
|
| 20% PEP and TISSEEL | Experimental | Cohort 3: Subjects will receive 20% PEP and TISSEEL to the skin graft donor wound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% PEP | Biological | PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute dose limiting toxicities (DLTs) of PEP / PEP-Tisseel | The primary endpoint is to determine the acute (within first 14 days) safety and tolerability of PEP or PEP-TISSEEL, as assessed by the occurrence of DLTs on a 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure) skin graft donor site wound at escalating concentrations of PEP delivered at one time point through the 14-day DLT period. | Up to 2 weeks (within the first 14 days) for each dosing cohort |
| Maximum Tolerated Dose (MTD) of PEP / PEP-Tisseel | The endpoint is to determine the acute (within first 14 days) safety and tolerability of PEP or PEP-TISSEEL, as assessed by the occurrence of MTDs on a 20-40 cm2 (but can be up to 90 cm2 if found to be clinically indicated during the graft procedure) skin graft donor site wound at escalating concentrations of PEP delivered at one time point through the 14-day MTD period. | Up to 2 weeks (within the first 14 days) for each dosing cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Long Term safety of PEP / PEP-Tisseel | The secondary endpoint is to determine the safety and tolerability of a single dose of PEP or PEP-Tisseel delivered at a single time point, as assessed by the occurrence of DLTs through the Day 15-182 DLT period | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint | The exploratory endpoint is to assess wound closure as defined as 100% re-epithelialization after treatment with PEP and PEP-TISSEEL. | 6 months |
Main Criteria for Inclusion:
Males and females 18-75 years of age.
Requiring at least two 20-40 cm2 split-thickness skin grafts by a licensed surgeon or dermatologist
Skin graft that meets all the following criteria:
Ability to safely undergo skin graft harvest procedure
Capacity to provide informed consent
Ability to comply with protocol
Subject is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, vital signs, and clinical laboratory tests
Subject is able and willing to return to study site for all follow-up visits
Main Criteria for Exclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Sabbah, MD | Rion Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Research Partners | Doral | Florida | 33122 | United States | ||
| Mayo Clinic in Rochester |
Not provided
| Label | URL |
|---|---|
| Rion company website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TISSEEL | Drug | Fibrin sealant made from pooled human plasma |
|
|
| 20% PEP | Biological | PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors. |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |