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Surgical excisions are one of the most frequent cutaneous wounds. This study will compare the safety and preliminary efficacy of a novel fixed-dose combination drug MRG-001 in pre-abdominoplasty surgical excisions and scar appearance in subjects undergoing elective abdominoplasty.
Subjects will undergo surgical excisions in the abdominoplasty area and will be treated with MRG-001 or placebo for 3 weeks. After 6 weeks, the excision area is harvested for analysis and the study is terminated and the abdominoplasty is performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRG-001 | Experimental | MRG-001 will be administered subcutaneously at 0.01 mL/kg bodyweight 3 times per week for 3 weeks. |
|
| Saline | Placebo Comparator | Placebo will be administered subcutaneously at 0.01 mL/kg bodyweight 3 times per week for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRG-001 | Drug | MRG-001 is a novel fixed-dose drug combination administered subcutaneously to mobilize stem cells and immunomodulatory cells to the wound to accelerate healing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the preliminary effectiveness of MRG-001 treatment on tensile strength of the scars. The difference in Newton force will be compared between saline and MRG-001. | Week -6 to 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of MRG-001 treatment compared to placebo controls. The number of (serious) adverse events will be compared between MRG-001 and placebo | Week -6 to 0 | |
| Evaluate the pharmacokinetics of MRG-001 (plerixafor and tacrolimus) in patients with wounds. The following parameters will be assessed: Maximum concentration, trough levels, Minimum concentrations, Clearance and half-life. |
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Inclusion Criteria:
Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent (which includes the Photographic Release Form and HIPAA) prior to performing any of the Screening Visit procedures.
Outpatient, males and females between 18 to 55 years of age, inclusive, at the time of signing the ICF. Female subjects of childbearing potential must have a negative serum pregnancy test at Visit 1a (Study Part A) and 1b (Study Part B) and practice a reliable method of contraception throughout the study.
Seeking or scheduled for standard elective abdominoplasty.
Willing to undergo directed excisions under local anesthesia and follow-up prior abdominoplasty and to undergo all follow-up visits after abdominoplasty surgery.
Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months) and by urine cotinine concentration (< 200 ng/mL) at the Screening Visit and prior to admission.
Generally, in good health with no clinically significant abnormalities as determined by medical, history, physical examination, 12-lead ECG and clinical laboratory tests.
The following applies to female subjects of childbearing potential:
• Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide or intrauterine device) from the Screening Visit until the End-of-study Visit.
Body mass index (BMI) between 25 and 35.0 kg/m2, inclusive, at the Screening Visit.
Men must be willing to use double-barrier contraception from enrollment until 8 weeks after the last dose of the study drug, if not abstinent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D Galiano, MD FACS | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | Sterile saline will serve as placebo treatment. |
|
| Week -6 to 0 |
| Evaluate the pharmacodynamics of wound healing with MRG-001 treatment by measuring the presence of stem cells and immune cells in the peripheral blood and granulation tissue compared to placebo controls. | Week -6 to 0 |
| Assess the time to full re-epithelization of the wounds assessed by digital photography by three independent plastic surgeons. | Week -6 to 0 |
| Assess the scar appearance by the modified POSAS (PI & Patient) at 6 weeks. | Week -6 to 0 |
| Assess the difference in VAS pain scores. | Week -6 to 0 |
| Incidence of wound infection requiring antibiotic therapy within 28 days after excision. | Week -6 to 0 |
| Assess the effect of MRG-001 on the histological presence of stem cells and immunoregulatory cells in the scars. The number of CD133+, CD34+ FOXP3+, Macrophages will be compared between MRG-001 and placebo in the wound area. | Week -6 to 0 |
| D017670 |
| Sodium Compounds |