An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
Condition: Arteriovenous Fistula
MeSH terms: Arteriovenous Fistula; Fistula
Intervention: SRM003; Participating Site's standard practice
Intervention description: One time implant (2 SRM003 pieces) on surgery day.; Subjects will receive sites' standard practice treatment during the surgical procedure.
Intervention MeSH terms: Gelatin Sponge, Absorbable
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arteriovenous Fistula Surgery; Vascular Injury; Hemodialysis Access

Summary:

      A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard
      practice treatment in improving the rate of AVF maturation and use in subjects with end-stage
      renal disease undergoing surgery for creation of an AVF to facilitate hemodialysis access.

      It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin
      matrix containing endothelial cells can provide a continuous supply of multiple growth
      regulatory compounds to the underlying cells within the blood vessel, while being protected
      from the effects of blood flow in the vessel(s) or complications resulting from being in
      direct contact with the point of injury.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject must be 18 years of age or older at the time of signing and dating informed
             consent (no upper age limit), can be male or female.

          2. Subject who is of child bearing potential must agree to use adequate contraception for
             6 months after randomization.

          3. Subject must be currently undergoing hemodialysis or anticipating the start of
             hemodialysis and must require a new permanent, suitable access for the AVF creation in
             the upper extremity.

          4. Subject must have a life expectancy of at least 26 weeks after randomization.

          5. Subject must be able to understand and be willing to complete all study requirements.

        Exclusion Criteria:

          1. Subject is currently on an active organ transplant list from a deceased donor or is
             undergoing assessment and expects to be placed on the active organ or bone marrow
             transplant list within the next 26 weeks from surgery, or expects to receive a living
             donor organ or bone marrow within the next 26 weeks and is unwilling to change
             transplant list status to "hold" for 3 months after randomization.

          2. Subject has had more than 1 access placement surgery (defined as a new access, not a
             revision) in the target limb.

          3. Subject has medical conditions and diseases that may cause non-compliance with the
             protocol

          4. Subject has a known allergy to bovine/porcine products or collagen/gelatin products.

          5. Subject has a history of intravenous drug use within 6 months prior to screening

          6. Subject is morbidly obese, defined as having a body mass index >40.

          7. Pregnant or nursing woman, or plans to become pregnant during the study.