Bio ACL Reconstruction Amnion Collagen Matrix Wrap and Stem Cells

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)

The use of a collagen based -membrane derived from amniotic tissue may 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.

Inclusion Criteria:

- Patients between the ages of 18 and 45 who are scheduled to have anterior cruciate
ligament reconstruction with autologous grafts by one of the investigating physicians
will be screened for participation in this study.

- Patients must be willing to undergo MRI scans post -operatively at 3, 6, 9 months and
1 year

Exclusion Criteria:

- Patients with prior procedures or significant prior injuries to the same knee are
excluded. - - Any patient who will have difficulty obtaining internet access, does not
have an active e-mail address, or is unable to comprehend study documents or give
informed consent will be excluded.

- Patient who are unable to complete MRI examinations due to claustrophobia or anxiety
will be excluded.