A Phase 1 interventional study of Bio-ACL and amnion wrap and BMAC in ACL - Anterior Cruciate Ligament Rupture, sponsored by Andrews Research & Education Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-01.
Sponsored by Andrews Research & Education Foundation · Phase 1, Interventional, and Treatment
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
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.
Exclusion Criteria:
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.
Procedure: Bio-ACL · Device: amnion wrap and BMAC
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
MRI graft maturation and integration
validated T2 star sequence which will undergo region of interest mapping to produce mean T2 values. These values have been shown to detect differences in ACL content, structure and maturation.
Time frame: 3 months, 6 months, 9 months, and 12 months post-op
Changes in patient-reported pain rating
Visual analog scale will be used to assess pain
Time frame: 3 months, 6 months, 9 months, 12 months post-op
Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)
Patients will complete KOOS questionnaire on SOS
Time frame: 3 months, 6 months, 9 months, 12 months post-op
Changes in Short Form 12 (SF-12) patient ratings
Patients will complete SF-12 questionnaire on SOS
Time frame: 3 months, 6 months, 9 months, 12 months post-op
Changes in Single Assessment Numerical Evaluation (SANE) patient ratings for function
Patients will complete the SANE questionnaire on SOS
Time frame: 3 months, 6 months, 9 months, 12 months post-op
Marx Activity Scale Rating
Patients will complete the Marx Activity questionnaire on SOS
Time frame: 3 months, 6 months, 9 months, 12 months post-op
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Andrews Research & Education Foundation