COMPLETED

Safety and Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients

Conditions

Wound of Skin Abdominal Wound Abdominoplasty Surgical Excision Wound Healing MRG-001 Scar Formation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Efficacy of MRG-001 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions

Quick Facts

Study Start:2023-11-20

Study Completion:2024-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05844527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. 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. 3. Seeking or scheduled for standard elective abdominoplasty. 4. Willing to undergo directed excisions under local anesthesia and follow-up prior abdominoplasty and to undergo all follow-up visits after abdominoplasty surgery. 5. 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. 6. Generally, in good health with no clinically significant abnormalities as determined by medical, history, physical examination, 12-lead ECG and clinical laboratory tests. 7. The following applies to female subjects of childbearing potential: 8. Body mass index (BMI) between 25 and 35.0 kg/m2, inclusive, at the Screening Visit. 9. 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.	1. Participation in any other clinical trial of an experimental treatment or used an investigational drug within the past 30 days. 2. Subject has a clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematological or psychiatric disorder(s) as determined by the Principal Investigator or designee. 3. History of diabetes mellitus or an HbA1C greater than 5.7 percent. 4. History of prior abdominal surgery or abdominal liposuction, cryolipolysis, focused ultrasound or other fat reduction procedures in or near the anterior abdomen within 12 months prior to screening. 5. History of poor or delayed wound healing such as prior wound dehiscence, chronic wound or leg ulcer. 6. History of or evidence of a genetic collagen disorder such as Ehlers-Danlos Syndrome. 7. Operating Physician is unable to design an abdominoplasty incision area of at least 25 cm wide by 12 cm tall at the center of the fusiform. 8. The presence of any abnormality of the skin within the area of the proposed abdominoplasty that, in the opinion of the PI, could interfere with the excision process or grading of the resultant surgical scar (e.g., striae gravidarum, striae distensae, excessive nevi, numerous seborrheic keratoses, tattoos, etc.). 9. History of splenectomy or splenomegaly (spleen weighing \>750 g). 10. Currently taking immunomodulating drugs (e.g, interferons, interleukin, JAK1/2 inhibitors/corticosteroids). 11. Female subjects who are pregnant or breastfeeding or planning to breastfeed at any time through 90 days after last dose of IP. 12. History of alcohol and/or illicit drug abuse within 2 years of entry. 13. History of hypersensitivity to MRG-001's components (tacrolimus or plerixafor) or hypersensitivity or intolerance to local anesthetics. 14. Any personal, familial, employment or financial situation that could impede the subject's ability to attend all study visits and successfully complete the entire clinical study. 15. Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study. 16. Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study. 17. Subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., vulnerable populations, persons in detention, minors and those incapable of giving consent).

Inclusion Criteria

Exclusion Criteria

1. 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.
2. 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.
3. Seeking or scheduled for standard elective abdominoplasty.
4. Willing to undergo directed excisions under local anesthesia and follow-up prior abdominoplasty and to undergo all follow-up visits after abdominoplasty surgery.
5. 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.
6. Generally, in good health with no clinically significant abnormalities as determined by medical, history, physical examination, 12-lead ECG and clinical laboratory tests.
7. The following applies to female subjects of childbearing potential:
8. Body mass index (BMI) between 25 and 35.0 kg/m2, inclusive, at the Screening Visit.
9. 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.

1. Participation in any other clinical trial of an experimental treatment or used an investigational drug within the past 30 days.
2. Subject has a clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematological or psychiatric disorder(s) as determined by the Principal Investigator or designee.
3. History of diabetes mellitus or an HbA1C greater than 5.7 percent.
4. History of prior abdominal surgery or abdominal liposuction, cryolipolysis, focused ultrasound or other fat reduction procedures in or near the anterior abdomen within 12 months prior to screening.
5. History of poor or delayed wound healing such as prior wound dehiscence, chronic wound or leg ulcer.
6. History of or evidence of a genetic collagen disorder such as Ehlers-Danlos Syndrome.
7. Operating Physician is unable to design an abdominoplasty incision area of at least 25 cm wide by 12 cm tall at the center of the fusiform.
8. The presence of any abnormality of the skin within the area of the proposed abdominoplasty that, in the opinion of the PI, could interfere with the excision process or grading of the resultant surgical scar (e.g., striae gravidarum, striae distensae, excessive nevi, numerous seborrheic keratoses, tattoos, etc.).
9. History of splenectomy or splenomegaly (spleen weighing \>750 g).
10. Currently taking immunomodulating drugs (e.g, interferons, interleukin, JAK1/2 inhibitors/corticosteroids).
11. Female subjects who are pregnant or breastfeeding or planning to breastfeed at any time through 90 days after last dose of IP.
12. History of alcohol and/or illicit drug abuse within 2 years of entry.
13. History of hypersensitivity to MRG-001's components (tacrolimus or plerixafor) or hypersensitivity or intolerance to local anesthetics.
14. Any personal, familial, employment or financial situation that could impede the subject's ability to attend all study visits and successfully complete the entire clinical study.
15. Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study.
16. Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study.
17. Subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., vulnerable populations, persons in detention, minors and those incapable of giving consent).

Contacts and Locations

Principal Investigator

Robert D Galiano, MD FACS

PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Study Locations (Sites)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: MedRegen LLC

Robert D Galiano, MD FACS, PRINCIPAL_INVESTIGATOR, Northwestern University Feinberg School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-20

Study Completion Date2024-09-01

Study Record Updates

Study Start Date2023-11-20

Study Completion Date2024-09-01

Terms related to this study

Keywords Provided by Researchers

Abdominoplasty
Surgical Excision
Wound Healing
MRG-001
Scar Formation

Additional Relevant MeSH Terms

Wound of Skin
Abdominal Wound