← Back to Search

Bioscaffold

Enhanced Bioscaffold for Muscle Atrophy (MTEC-VML Trial)

N/A

Waitlist Available

Research Sponsored by J. Peter Rubin, MD

Eligibility Criteria Checklist

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

Must have

Age: 18 to 70 years of age and able to provide informed consent

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9-11 months

Awards & highlights

MTEC-VML Trial Summary

This trial will test a new type of surgical graft to see if it can help restore function after muscle loss due to trauma.

Who is the study for?

This trial is for adults aged 18-70 with muscle loss from injury, affecting key muscles like the Pectoralis Major or Gluteus group. Participants must have a structural and functional deficit in the affected muscle, be within 18 months post-injury (with some flexibility), and able to follow study procedures. Exclusions include poor nutrition, chronic diseases, unstable health conditions, pregnancy, recent cancer treatments, mental health disorders without clearance, allergies to porcine products or specific antibiotics.Check my eligibility

What is being tested?

The University of Pittsburgh is conducting a study on XenMatrix™ AB Surgical Graft's effectiveness in restoring function after severe soft tissue trauma resulting in significant muscle loss. The graft aims to repair damaged muscles by providing a scaffold for new tissue growth.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions at the surgery site such as pain or infection; allergic responses especially if there's sensitivity to porcine products; and complications related to graft integration.

MTEC-VML Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

MTEC-VML Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9-11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9-11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9-11 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

extremity function (number of types of exercises)

extremity strength (number of repetitions of exercises)

Secondary outcome measures

Infection rate

MTEC-VML Trial Design

1Treatment groups

Experimental Treatment

Group I: XenMatrix AB Surgical GraftExperimental Treatment1 Intervention

This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval [#K162193] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

J. Peter Rubin, MDLead Sponsor

3 Previous Clinical Trials

43 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

327,689 Total Patients Enrolled

Media Library

XenMatrix™ AB Surgical Graft (Bioscaffold) Clinical Trial Eligibility Overview. Trial Name: NCT04051242 — N/A

Muscle Atrophy Research Study Groups: XenMatrix AB Surgical Graft

Muscle Atrophy Clinical Trial 2023: XenMatrix™ AB Surgical Graft Highlights & Side Effects. Trial Name: NCT04051242 — N/A

XenMatrix™ AB Surgical Graft (Bioscaffold) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04051242 — N/A

Frequently Asked Questions

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

Do I meet the qualifications to be part of this experiment?

"This clinical experiment is searching for 10 participants, aged between 18-70 with muscular tissue. These individuals must have experienced an injury leading to a minimum 20% structural deficit and 25% functional impairment compared to the unharmed limb; when dual extremities are affected, normal expected values of similar age and gender will be used for comparison by imaging studies or physical exam. Injuries may include single muscle compartments that can be restored through sutures as well as musculotendinous units attached to long bones which affect strength or function (i.e., Pectoralis Major, Coracobrachialis etc.) The"

Answered by AI

How many participants are being recruited for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this experiment which was initially posted on February 10th 2020 is actively recruiting volunteers. A total of 10 test subjects are required at a single site."

Answered by AI

Is there an ongoing recruitment of participants for this experiment?

"As per the information on clinicaltrials.gov, this medical trial is currently open for recruitment of subjects. It was first revealed to the public on 10th February 2020 and has recently been updated in December 2022."

Answered by AI

Are individuals aged sixty and above being included in this experiment?

"In order to be eligible for this medical trial, the age of participants must range between 18 and 70 years old. Additionally, there are 1 trials designed specifically for those under 18 while 13 studies accommodate seniors over 65."

Answered by AI

Recent research and studies

Physical TherapyJournal

Electrodiagnostic Evaluation of Individuals Implanted with Extracellular Matrix for the Treatment of Volumetric Muscle Injury: Case Series

Han, Nami, Mohammad A. Yabroudi, Kristen Stearns-Reider, Wendy Helkowski, Brian M. Sicari, J. Peter Rubin, Stephen F. Badylak, Michael L. Boninger, and Fabrisia Ambrosio. 2016. “Electrodiagnostic Evaluation of Individuals Implanted with Extracellular Matrix for the Treatment of Volumetric Muscle Injury: Case Series”. Physical Therapy. Oxford University Press (OUP). doi:10.2522/ptj.20150133.

npj Regenerative MedicineJournal

An Acellular Biologic Scaffold Treatment for Volumetric Muscle Loss: Results of a 13-patient Cohort Study

Dziki, Jenna, Stephen Badylak, Mohammad Yabroudi, Brian Sicari, Fabrisia Ambrosio, Kristen Stearns, Neill Turner, et al.. 2016. “An Acellular Biologic Scaffold Treatment for Volumetric Muscle Loss: Results of a 13-patient Cohort Study”. Npj Regenerative Medicine. Springer Science and Business Media LLC. doi:10.1038/npjregenmed.2016.8.

npj Regenerative MedicineJournal

An Acellular Biologic Scaffold Treatment for Volumetric Muscle Loss: Results of a 13-patient Cohort Study

clinicaltrials.govStudy

Enhanced Bioscaffold for Volumetric Muscle Loss