Bio ACL Reconstruction Amnion Collagen Matrix Wrap and Stem Cells

NCT03294759 | Active Not Recruiting DMC

• 1 other identifier: Bio ACL (RCT)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ACL - Anterior Cruciate Ligament Rupture

Keywords

amion; stem cell; acl

Outcome Measures

Primary Outcomes (1)

• Changes in ACL

  MRI region of interest mapping to produce mean T2 values

  3 months, 6 months, 9 months, 12 months post-op

Secondary Outcomes (5)

• Changes in patient-reported pain rating

  3 months, 6 months, 9 months, 12 months post-op

• Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)

  3 months, 6 months, 9 months, 12 months post-op

• Changes in Short Form 12 (SF-12) patient ratings

  3 months, 6 months, 9 months, 12 months post-op

• Changes in Single Assessment Numerical Evaluation (SANE) patient ratings for function

  3 months, 6 months, 9 months, 12 months post-op

• Marx Activity Scale Rating

  12 months post-op

Study Arms (2)

Bio-ACL (Amion)

EXPERIMENTAL

Intervention: ACL Autograft Reconstruction with Amion Collagen Scaffold. Stem Cells isolated from bone marrow aspirate from distal femur will be injected inside the Amion Collagen Scaffold.

Other: Bio ACL

Control

ACTIVE COMPARATOR

Intervention: Normal ACL Autograft Reconstruction with either patella or hamstring autograft will be performed in the control group.

Other: Control

Interventions

Bio ACL OTHER

Bone marrow aspirate will be centrifuged using the Arthrex Angel system to optimally concentrate the cells for implantation. The graft for the experimental groups will be wrapped with a sterile amnion matrix wrap, supplied by Arthrex

Also known as: Amnion

Bio-ACL (Amion)

Control OTHER

Normal ACL reconstruction technique with either patella or hamstring autograft

Also known as: Standard ACLr

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Andrews Institute

Gulf Breeze, Florida, 32561, United States

Location

Related Publications (13)

• Claes S, Verdonk P, Forsyth R, Bellemans J. The "ligamentization" process in anterior cruciate ligament reconstruction: what happens to the human graft? A systematic review of the literature. Am J Sports Med. 2011 Nov;39(11):2476-83. doi: 10.1177/0363546511402662. Epub 2011 Apr 22.

  PMID: 21515806 BACKGROUND

• Matsumoto T, Kubo S, Sasaki K, Kawakami Y, Oka S, Sasaki H, Takayama K, Tei K, Matsushita T, Mifune Y, Kurosaka M, Kuroda R. Acceleration of tendon-bone healing of anterior cruciate ligament graft using autologous ruptured tissue. Am J Sports Med. 2012 Jun;40(6):1296-302. doi: 10.1177/0363546512439026. Epub 2012 Mar 16.

  PMID: 22427618 BACKGROUND

• Mifune Y, Matsumoto T, Takayama K, Terada S, Sekiya N, Kuroda R, Kurosaka M, Fu FH, Huard J. Tendon graft revitalization using adult anterior cruciate ligament (ACL)-derived CD34+ cell sheets for ACL reconstruction. Biomaterials. 2013 Jul;34(22):5476-87. doi: 10.1016/j.biomaterials.2013.04.013. Epub 2013 Apr 28.

  PMID: 23632324 BACKGROUND

• Joshi SM, Mastrangelo AN, Magarian EM, Fleming BC, Murray MM. Collagen-platelet composite enhances biomechanical and histologic healing of the porcine anterior cruciate ligament. Am J Sports Med. 2009 Dec;37(12):2401-10. doi: 10.1177/0363546509339915.

  PMID: 19940313 BACKGROUND

• Sanchez M, Anitua E, Azofra J, Prado R, Muruzabal F, Andia I. Ligamentization of tendon grafts treated with an endogenous preparation rich in growth factors: gross morphology and histology. Arthroscopy. 2010 Apr;26(4):470-80. doi: 10.1016/j.arthro.2009.08.019. Epub 2010 Jan 15.

  PMID: 20362825 BACKGROUND

• Radice F, Yanez R, Gutierrez V, Rosales J, Pinedo M, Coda S. Comparison of magnetic resonance imaging findings in anterior cruciate ligament grafts with and without autologous platelet-derived growth factors. Arthroscopy. 2010 Jan;26(1):50-7. doi: 10.1016/j.arthro.2009.06.030.

  PMID: 20117627 BACKGROUND

• DiDomenico LA, Orgill DP, Galiano RD, Serena TE, Carter MJ, Kaufman JP, Young NJ, Zelen CM. Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial. Plast Reconstr Surg Glob Open. 2016 Oct 12;4(10):e1095. doi: 10.1097/GOX.0000000000001095. eCollection 2016 Oct.

  PMID: 27826487 BACKGROUND

• Piontek T, Ciemniewska-Gorzela K, Naczk J, Jakob R, Szulc A, Grygorowicz M, Slomczykowski M. Complex Meniscus Tears Treated with Collagen Matrix Wrapping and Bone Marrow Blood Injection: A 2-Year Clinical Follow-Up. Cartilage. 2016 Apr;7(2):123-39. doi: 10.1177/1947603515608988. Epub 2015 Nov 30.

  PMID: 27047635 BACKGROUND

• Li H, Tao H, Cho S, Chen S, Yao Z, Chen S. Difference in graft maturity of the reconstructed anterior cruciate ligament 2 years postoperatively: a comparison between autografts and allografts in young men using clinical and 3.0-T magnetic resonance imaging evaluation. Am J Sports Med. 2012 Jul;40(7):1519-26. doi: 10.1177/0363546512443050. Epub 2012 Apr 11.

  PMID: 22495290 BACKGROUND

• Biercevicz AM, Akelman MR, Fadale PD, Hulstyn MJ, Shalvoy RM, Badger GJ, Tung GA, Oksendahl HL, Fleming BC. MRI volume and signal intensity of ACL graft predict clinical, functional, and patient-oriented outcome measures after ACL reconstruction. Am J Sports Med. 2015 Mar;43(3):693-9. doi: 10.1177/0363546514561435. Epub 2014 Dec 24.

  PMID: 25540298 BACKGROUND

• Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34. doi: 10.1177/0363546515612750. Epub 2015 Nov 19.

  PMID: 26585668 BACKGROUND

• Baeten D, Van den Bosch F, Elewaut D, Stuer A, Veys EM, De Keyser F. Needle arthroscopy of the knee with synovial biopsy sampling: technical experience in 150 patients. Clin Rheumatol. 1999;18(6):434-41. doi: 10.1007/s100670050134.

  PMID: 10638766 BACKGROUND

• Anz AW, Jordan SE, Ostrander RV 3rd, Branch EA, Denney TS, Cohen A, Andrews JR. Augmentation of ACL Autograft Reconstruction With an Amnion Collagen Matrix Wrap and Bone Marrow Aspirate Concentrate: A Pilot Randomized Controlled Trial With 2-Year Follow-up. Orthop J Sports Med. 2023 Nov 17;11(11):23259671231210035. doi: 10.1177/23259671231210035. eCollection 2023 Nov.

  PMID: 38021297 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

cancer procoagulant

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Adam Anz, MD

  Andrews Research & Education Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Bone marrow aspirate will be collected through the surgical site from the distal femur with a trocar designed for this purpose. Therefore patients will be unable to determine if they have had stem cells harvested
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ACL harvested for autograft reconstruction of the ACL with either hamstring or patellar tendon grafts. The graft will be wrapped in a collagen wrap and injection with aspirate from the patient's bone marrow. The control group will have standard ACL reconstruction with either hamstring or patellar tendon grafts.

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 27, 2017
• Study Start: September 6, 2017
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

US (1)