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MRG-001 for Abdominal Wound Healing

Phase 2

Recruiting

Led By Robert D Galiano, MD FACS

Research Sponsored by MedRegen LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week -6 to 0

Awards & highlights

Study Summary

This trial will test a new drug to reduce scarring from surgical excisions during abdominal plastic surgery.

Who is the study for?

This trial is for healthy non-smokers aged 18-55 who are planning to have an elective abdominoplasty. Participants must not use nicotine, have a BMI between 25-35, and agree to use reliable contraception if of childbearing potential. They should be in good health overall without significant medical issues.Check my eligibility

What is being tested?

The study tests MRG-001's safety and effectiveness on wound healing compared to saline in patients undergoing abdominoplasty. It aims to see how well the drug works on surgical excisions and scar appearance post-surgery.See study design

What are the potential side effects?

Potential side effects of MRG-001 are not detailed here but would typically include reactions at the application site or systemic responses due to medication absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week -6 to 0

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week -6 to 0

This trial's timeline: 3 weeks for screening, Varies for treatment, and week -6 to 0 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

Assess the difference in VAS pain scores.

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.

Assess the scar appearance by the modified POSAS (PI & Patient) at 6 weeks.

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MRG-001Experimental Treatment1 Intervention

MRG-001 will be administered subcutaneously at 0.01 mL/kg bodyweight 3 times per week for 3 weeks.

Group II: SalinePlacebo Group1 Intervention

Placebo will be administered subcutaneously at 0.01 mL/kg bodyweight 3 times per week for 3 weeks.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

MedRegen LLCLead Sponsor

4 Previous Clinical Trials

142 Total Patients Enrolled

Robert D Galiano, MD FACSPrincipal InvestigatorNorthwestern University Feinberg School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has MRG-001 received regulatory assent from the FDA?

"MRG-001's safety is rated at a 2, as the data gathered thus far indicates that it has not been proven to be effective but there are signs of its security."

Answered by AI

Is this research offering participation to adults greater than 35 years of age?

"According to the specified requirements for participation, potential participants must be between 18 and 55 years of age."

Answered by AI

Is this research protocol currently accepting participants?

"As can be seen on the clinicaltrials.gov website, this research is currently searching for participants to enroll into their trial. The study was initially made public on November 20th of 2021 and has recently been updated with new information as of that same day."

Answered by AI

What is the current enrollment quota for this clinical trial?

"Affirmative. As per information hosted on clinicaltrials.gov, this medical study is actively looking for participants with the most recent update being made on 11/20/2023. The trial was originally posted on November 20th and seeks 10 volunteers from a single site."

Answered by AI

Is my profile suitable for participation in this trial?

"This trial is recruiting participants aged 18-55 with skin wounds. Notable criteria for enrolment include voluntary participation, no smoking in the past 6 months, non-pregnancy and non-lactation status (for females of childbearing age), BMI between 25 to 35 kg/m2, contraception use (as applicable) from screening until end of study visit, and double barrier contraception where necessary. Additionally all must sign an IRB approved informed consent document as well as a photographic release form."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Safety and Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05844527.