BioACL Reconstruction With Amnion Collagen Matrix Wrap and Stem Cells Case Series
Condition: ACL - Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the use of wrapping an ACL graft with a collagen
      matrix tissue wrap and injecting autologous bone marrow aspirate concentrate under the
      wrapping and into the graft. Investigators hypothesize that this method of augmenting ACL
      surgery will accelerate and improve the graft maturation and ligamentization process.
      Investigators propose to test this hypothesis with a series of cases of ACL reconstructions
      evaluated with post-operative MRI mapping sequences and validated clinical outcome measures
    

Detailed description: 
      Histologic studies have determined that graft ligamentization following anterior cruciate
      ligament (ACL) reconstruction may take from 6 to 18 months. (1) It has been reported that
      incomplete graft maturation and incorporation is one cause of clinical graft failure. Animal
      studies have illustrated improved tendon healing/integration in ACL models augmented with
      stem cell technologies. (2-4). Basic scientists theorize that optimization of stem cell
      treatments for tissue regeneration requires that a "regenerative triad" be employed, i.e.,
      use of a scaffold, stem cells and growth factors. In the intra-articular environment,
      research has shown that a scaffold such as an amnion wrap is necessary to contain the stem
      cells and growth factors in close proximity to the ACL graft. (2, 4, 5) The normal, uninjured
      human ACL is covered by a layer of synovial tissue which contributes to the blood supply and
      nutrition of the native ACL. It is theorized that the lack of a synovial lining after injury
      and following traditional ACL reconstruction contributes to slow ligamentization and possible
      failure of reconstructed grafts.(5) Two studies have demonstrated accelerated maturation and
      ligamentization of human ACL graft augmented with point of care blood products. (6, 7) In
      one, leucocyte poor platelet rich plasma was injected directly into the body of the graft.
      (6) In the other, the platelet derived growth factors were loaded in a gelatin carrier which
      was wrapped around the graft. (7) In both studies accelerated and increased ligament
      maturation was documented compared to the controls. Collagen membranes derived from amniotic
      tissue have been successful to aid healing when used in difficult wounds and meniscal repair
      surgery. (8, 9) Investigators believe that use of a collagen based -membrane derived from
      amniotic tissue can be used to help reestablish the natural synovial lining of the
      reconstructed ACL, in effect acting as both a barrier from the synovial fluid and as a
      scaffold to contain autologous mesenchymal stem cells and growth factors contiguous with the
      graft, thus aiding and perhaps accelerating the natural maturation and ligamentization
      process of the implanted graft tissue. Acceleration and improvement in graft maturation and
      strength would be a significant advancement in sports medicine allowing safer and earlier
      return to sports and activity.
    

Intervention name(s): Bio-ACL; amnion wrap and BMAC
Intervention type(s): Procedure; Device
Intervention description(s): ACL reconstruction with either hamstring or patellar autograft, wrapped in amion collagen wrap, and stem cells from bone marrow aspirate.; amnion collagen wrap and bone-marrow aspirate in ACL reconstruction autograft
Intervention model: Single Group Assignment
Intervention model description: Normal ACL reconstruction with either patellar or hamstring autograft will be done and prior to fixation the graft will be wrapped in a amion collagen wrap. Bone marrow aspirate will be obtained from distal femur at the time of the arthroscopy and stem cells isolated using the Arthrex Angel System. These stem cells with be under direct visualization impregnated into the ACL autograft amion wrap complex.
Masking: None (Open Label)
Primary purpose: Treatment