Your session is about to expire
← Back to Search
Stem Cell Therapy
Bio ACL Reconstruction for Anterior Cruciate Ligament Rupture (BioACLRCT Trial)
N/A
Waitlist Available
Led By Adam Anz, MD
Research Sponsored by Andrews Research & Education Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months, 9 months, 12 months post-op
Awards & highlights
BioACLRCT Trial Summary
This trial is testing a new type of ACL surgery that uses a collagen-based membrane derived from amniotic tissue. The hope is that this will help the new ACL ligament to better heal and mature, allowing people to safely return to sports and other activities sooner.
Who is the study for?
This trial is for individuals aged 18-45 who are about to have ACL reconstruction with their own tissue grafts. They must be able to get MRI scans post-surgery and have internet access, an email address, and the ability to understand study documents.Check my eligibility
What is being tested?
The trial is testing a collagen-based membrane from amniotic tissue wrapped around the reconstructed ACL, potentially with stem cells. This may speed up healing and strengthen the graft, allowing quicker return to sports.See study design
What are the potential side effects?
Potential side effects aren't specified in this summary but could include typical surgical risks like infection or reaction to materials used in the wrap or complications related to MRI procedures.
BioACLRCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months, 6 months, 9 months, 12 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months, 9 months, 12 months post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in ACL
Secondary outcome measures
Changes in Knee injury and Osteoarthritis Outcome Score (KOOS)
Changes in Short Form 12 (SF-12) patient ratings
Changes in Single Assessment Numerical Evaluation (SANE) patient ratings for function
+2 moreBioACLRCT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bio-ACL (Amion)Experimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Intervention: Normal ACL Autograft Reconstruction with either patella or hamstring autograft will be performed in the control group.
Find a Location
Who is running the clinical trial?
Andrews Research & Education FoundationLead Sponsor
18 Previous Clinical Trials
839 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Rupture
40 Patients Enrolled for Anterior Cruciate Ligament Rupture
Arthrex, Inc.Industry Sponsor
44 Previous Clinical Trials
29,842 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Rupture
450 Patients Enrolled for Anterior Cruciate Ligament Rupture
Adam Anz, MDPrincipal InvestigatorAndrews Research & Education Foundation
7 Previous Clinical Trials
330 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had surgery or major injuries to my knee before.I am between 18 and 45 years old and scheduled for ACL reconstruction with my own tissue.I am willing to have MRI scans after surgery at 3, 6, 9 months, and 1 year.
Research Study Groups:
This trial has the following groups:- Group 1: Bio-ACL (Amion)
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Popular Categories
Share this study with friends
Copy Link
Messenger