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

NCT03294720 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-02-01

No results posted yet for this study

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

Interventions

PROCEDURE

Bio-ACL

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

DEVICE

amnion wrap and BMAC

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

Sponsors & Collaborators

  • Arthrex, Inc.

    collaborator INDUSTRY

  • Andrews Research & Education Foundation

    lead OTHER

Principal Investigators

  • Adam Anz, MD · Andrews Insituite for Sports and Orthopaedics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2022-08-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294720 on ClinicalTrials.gov