Wound of SkinPhase 2NCT05844527
Safety and Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients
A Phase 2 study testing MRG-001 and Saline in people with Wound of Skin and Abdominal Wound, run by MedRegen LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound of Skin, Abdominal Wound
- What is being tested?
- MRG-001 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 1 Sep 2024
- Phase
- Phase 2
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Participation in any other clinical trial of an experimental treatment or used an investigational drug within the past 30 days.
- 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.
- History of diabetes mellitus or an HbA1C greater than 5.7 percent.
- 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.
- History of poor or delayed wound healing such as prior wound dehiscence, chronic wound or leg ulcer.
- History of or evidence of a genetic collagen disorder such as Ehlers-Danlos Syndrome.
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- 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.
- 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.).
- History of splenectomy or splenomegaly (spleen weighing >750 g).
- Currently taking immunomodulating drugs (e.g, interferons, interleukin, JAK1/2 inhibitors/corticosteroids).
- Female subjects who are pregnant or breastfeeding or planning to breastfeed at any time through 90 days after last dose of IP.
- History of alcohol and/or illicit drug abuse within 2 years of entry.
- History of hypersensitivity to MRG-001's components (tacrolimus or plerixafor) or hypersensitivity or intolerance to local anesthetics.
- 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.
- Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study.
- 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.
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Safety and Efficacy of MRG-001 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions
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.
Read the detailed description
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.
- Conditions
- Wound of Skin, Abdominal Wound
- Being tested
- MRG-001, Saline
- Keywords
- Abdominoplasty, Surgical Excision, Wound Healing, MRG-001, Scar Formation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRG-001Drug
MRG-001 is a novel fixed-dose drug combination administered subcutaneously to mobilize stem cells and immunomodulatory cells to the wound to accelerate healing.
SalineDrug
Sterile saline will serve as placebo treatment.
| Study group | Role | What they receive |
|---|---|---|
| MRG-001 | Experimental | MRG-001 will be administered subcutaneously at 0.01 mL/kg bodyweight 3 times per week for 3 weeks. Receives: Drug: MRG-001 |
| Saline | Placebo comparator | Placebo will be administered subcutaneously at 0.01 mL/kg bodyweight 3 times per week for 3 weeks. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week -6 to 0
Secondary outcomes (8)
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
Measured: 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.
Measured: 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.
Measured: Week -6 to 0
Assess the time to full re-epithelization of the wounds assessed by digital photography by three independent plastic surgeons.
Measured: Week -6 to 0
Assess the scar appearance by the modified POSAS (PI & Patient) at 6 weeks.
Measured: Week -6 to 0
Assess the difference in VAS pain scores.
Measured: Week -6 to 0
Incidence of wound infection requiring antibiotic therapy within 28 days after excision.
Measured: 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.
Measured: Week -6 to 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start20 Nov 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedRegen LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert D Galiano, MD FACS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844527
- Sponsor's protocol ID
- MRG2023WH
- Status last verified
- Sep 2025
- First submitted
- 13 Apr 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of MRG-001 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions
- ClinicalTrials.gov ID
- NCT05844527
- Acronym / sponsor ID
- MRG2023WH
- Conditions
- Wound of Skin, Abdominal Wound
- Keywords
- Abdominoplasty, Surgical Excision, Wound Healing, MRG-001, Scar Formation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MedRegen LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 May 2023 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRG-001 | Experimental | Drug: MRG-001MRG-001 will be administered subcutaneously at 0.01 mL/kg bodyweight 3 times per week for 3 weeks. |
| Saline | Placebo comparator | Drug: SalinePlacebo will be administered subcutaneously at 0.01 mL/kg bodyweight 3 times per week for 3 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- Participation in any other clinical trial of an experimental treatment or used an investigational drug within the past 30 days.
- 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.
- History of diabetes mellitus or an HbA1C greater than 5.7 percent.
- 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.
- History of poor or delayed wound healing such as prior wound dehiscence, chronic wound or leg ulcer.
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 |
|---|---|---|
| MRG-001MRG-001 is a novel fixed-dose drug combination administered subcutaneously to mobilize stem cells and immunomodulatory cells to the wound to accelerate healing. | Drug | MRG-001 |
| SalineSterile saline will serve as placebo treatment. | Drug | Saline |
Primary outcome
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.
Time frame: Week -6 to 0
8 secondary outcomes
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
Time frame: 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.
Time frame: 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.
Time frame: Week -6 to 0
Assess the time to full re-epithelization of the wounds assessed by digital photography by three independent plastic surgeons.
Time frame: Week -6 to 0
Assess the scar appearance by the modified POSAS (PI & Patient) at 6 weeks.
Time frame: Week -6 to 0
Assess the difference in VAS pain scores.
Time frame: Week -6 to 0
Incidence of wound infection requiring antibiotic therapy within 28 days after excision.
Time frame: 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.
Time frame: Week -6 to 0
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 8 Sep 2025.
- 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.
Robert D Galiano, MD FACS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRG-001 and Saline in people with Wound of Skin and Abdominal Wound, run by MedRegen LLC 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 17 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 8 Sep 2025. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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. (time frame: Week -6 to 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.