Status:
TERMINATED
Enhanced Bioscaffold for Volumetric Muscle Loss
Lead Sponsor:
J. Peter Rubin, MD
Collaborating Sponsors:
United States Department of Defense
Conditions:
Muscle Loss
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a prospective, single center study conducted at the University of Pittsburgh designed to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in th...
Detailed Description
Previously, a human subject clinical trial (NCT01292876, PRO10010500) to evaluate a regenerative medicine approach using ECM for VML treatment was conducted. ECM scaffolds were implanted and combined ...
Eligibility Criteria
Inclusion
- Age: 18 to 70 years of age and able to provide informed consent
- Civilian, and current or former military personnel are eligible to participate
- Have suffered injury resulting in a structural deficit of a minimum of 20% of the muscle group mass and a functional deficit of a minimum of 25% when compared to a contralateral limb present; or if bilateral injury is present to extremities, the potential surgical extremity is to be compared against normal expected values of a sample population of similar age and gender and evidence of remaining tendon and musculotendinous units that could be surgically repaired with sutures.
- Injuries may encompass a single muscle belly or compartment, whether an area is expected to be repaired by sutures will be determined from imaging studies and physical examination. Muscle groups which originate or attach to the long bones of the extremity, and which directly affect strength and function (i.e., Pectoralis Major, Coracobrachialis, Subscapularis, Teres Major/Minor, Latissimus Dorsi, Supraspinatus, Infraspinatus, Gluteus group, Tensor fasciae latae, Piriformis, and quadratus femoris) will also be included in this clinical trial.
- Have suffered traumatic injury within the last 18 months to the upper and/or lower extremity; Target of 18 months or less but subject's may be enrolled with injury outside this range if the principal investigator determines that there is viable muscle in the injured compartment determined by clinical exam and imaging studies.
- Eligible for study procedures 3 months post injury with stability determined by the Principal Investigator and/ or Physician Co-Investigator
- Willing and able to comply with follow up examinations, radiographic studies, physical therapy, muscle biopsy and laboratory tests.
Exclusion
- Inability to provide informed consent
- Poor nutrition (demonstrated by clinically significant abnormal lab results for serum albumin and pre-albumin values, per the investigator's discretion)
- Chronic disease such as congestive heart failure, liver disease, renal disease, or diabetes
- Active and unstable disease state or infection anywhere in the body per Physician's evaluation and determination (demonstrated by stated or medical record history and abnormal lab range for CBC with Differential and Platelet, Liver function and chemistry panel values)
- Known coagulopathy (demonstrated by stated or medical record history of diagnosis)
- Pregnancy (demonstrated by a positive result of a urine pregnancy test)• Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment
- Subjects with an Axis I diagnosis DSM-IV (e.g., Schizophrenia, Bipolar Disorder). Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion
- .• Subjects with complete muscle/tendon gaps greater than 5 cm that are obvious on imaging studies and are unlikely to be reasonably repaired with sutures and reinforcement, and will be excluded. The investigators recognize that these findings may not be clear on imaging studies, and that the clinical judgment of the surgeon shall be applied in each case.
- Subjects with a known hypersensitivity to porcine serum products
- Allergies to the antibiotics, Rifampin, minocycline, tetracycline currently associated with the XenMatrix AB Surgical Graft
- Any condition or situation as it relates to the subject's health or safety, that would render concern to the investigators, and therefore preclude subject enrollment in the study.
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04051242
Start Date
February 10 2020
End Date
January 24 2024
Last Update
April 25 2025
Active Locations (1)
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1
UPMC Aesthetic Plastic Surgery Center
Pittsburgh, Pennsylvania, United States, 15213