What side effects are associated with this type of intervention?

Common treatments for muscle atrophy, especially those involving scaffolds for tissue regeneration and repair like XenMatrix™ AB Surgical Graft, may include surgical implantation of bioscaffolds, stem cell therapy, and other regenerative techniques. Known side effects of these treatments can include infection at the implantation site, immune reactions to the graft material, and inflammation. Additionally, there may be risks associated with the surgical procedure itself, such as bleeding and pain. Long-term studies are needed to fully understand the potential for adverse effects and the efficacy of these treatments in restoring muscle function.

What prior FDA approvals exist?

FDA-approved treatments for muscle atrophy primarily include pharmacological agents and biologics aimed at slowing muscle degeneration and promoting muscle growth. For example, glucocorticoids like prednisone are commonly used in conditions such as Duchenne Muscular Dystrophy to slow muscle degeneration. Eteplirsen, an exon-skipping drug, has also been approved for Duchenne Muscular Dystrophy to increase dystrophin production. While specific scaffold-based treatments like XenMatrix™ AB Surgical Graft are still under investigation, the FDA has approved various regenerative medicine approaches, including stem cell therapies, for other conditions, which may offer insights into future approvals for muscle atrophy treatments.

What other types of research exist?

Promising alternatives to XenMatrix™ AB Surgical Graft for muscle atrophy patients include: 1) Decellularized matrices seeded with human bone marrow stromal cells (hBMSC), which have shown improved structural stability and potential for tendon and ligament repair. 2) Mesenchymal stem cells (MSCs) secreting neurotrophic factors, which have demonstrated safety and clinical benefits in early-stage trials for various conditions. 3) Enhanced bioscaffolds designed for volumetric muscle loss, which are being tested for their applicability and utility in restoring muscle function after trauma.

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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

Must not have

Inability to provide informed consent

Chronic disease such as congestive heart failure, liver disease, renal disease, or diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9-11 months

Awards & highlights

Summary

This trial tests a special surgical patch called XenMatrix™ AB Surgical Graft to help patients with severe muscle loss from injuries. The patch supports new muscle growth and has antibiotics to prevent infections, aiming to improve muscle strength and function.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

You have a long-term illness like heart failure, liver disease, kidney disease, or diabetes.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

extremity function (number of types of exercises)

extremity strength (number of repetitions of exercises)

Secondary study objectives

Infection rate

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 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for muscle atrophy often involve the use of bioscaffolds, growth factors, and cell-based therapies. Bioscaffolds like the XenMatrix™ AB Surgical Graft provide a structural framework that supports tissue regeneration and repair by promoting cellular infiltration and vascularization. Growth factors activate satellite cells, which are essential for muscle regeneration and repair, thereby increasing muscle bulk and strength. Cell-based therapies, such as stem cell transplantation, aim to replace damaged muscle cells and enhance the regenerative capacity of the muscle tissue. These mechanisms are crucial for muscle atrophy patients as they address the underlying causes of muscle loss, promote tissue regeneration, and improve muscle function and strength.

Aligned nanofibers of decellularized muscle extracellular matrix for volumetric muscle loss.Muscle atrophy reversed by growth factor activation of satellite cells in a mouse muscle atrophy model.