BioACL Reconstruction With Amnion Collagen Matrix Wrap and Stem Cells Case Series

NCT03294720 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: BioACL (CS)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

ACL - Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months, 6 months, 9 months, and 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

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

Study Arms (1)

Bio ACL Reconstruction

EXPERIMENTAL

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

Interventions

Bio-ACL PROCEDURE

ACL reconstruction with either hamstring or patellar autograft, wrapped in amion collagen wrap, and stem cells from bone marrow aspirate.

Bio ACL Reconstruction

amnion wrap and BMAC DEVICE

amnion collagen wrap and bone-marrow aspirate in ACL reconstruction autograft

Bio ACL Reconstruction

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between the ages of 18 and 35 who are scheduled to have anterior cruciate ligament reconstruction with autologous grafts by the principal investigator 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

• Jang KM, Lim HC, Jung WY, Moon SW, Wang JH. Efficacy and Safety of Human Umbilical Cord Blood-Derived Mesenchymal Stem Cells in Anterior Cruciate Ligament Reconstruction of a Rabbit Model: New Strategy to Enhance Tendon Graft Healing. Arthroscopy. 2015 Aug;31(8):1530-9. doi: 10.1016/j.arthro.2015.02.023. Epub 2015 Apr 14.

  PMID: 25882182 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 J, Wang J, Li Y, Shao D, You X, Shen Y. A Prospective Randomized Study of Anterior Cruciate Ligament Reconstruction With Autograft, gamma-Irradiated Allograft, and Hybrid Graft. Arthroscopy. 2015 Jul;31(7):1296-302. doi: 10.1016/j.arthro.2015.02.033. Epub 2015 Apr 17.

  PMID: 25891223 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

• Beitzel K, McCarthy MB, Cote MP, Chowaniec D, Falcone LM, Falcone JA, Dugdale EM, Deberardino TM, Arciero RA, Mazzocca AD. Rapid isolation of human stem cells (connective progenitor cells) from the distal femur during arthroscopic knee surgery. Arthroscopy. 2012 Jan;28(1):74-84. doi: 10.1016/j.arthro.2011.06.035. Epub 2011 Oct 11.

  PMID: 21996407 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Adam Anz, MD

  Andrews Insituite for Sports and Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 27, 2017
• Study Start: January 8, 2018
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)