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ACL reconstruction utilizing stump-derived mesenchymal stem cells for Anterior Cruciate Ligament Tear (BioACL Trial)

N/A

Recruiting

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 younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post-operative

Awards & highlights

BioACL Trial Summary

This trial will compare outcomes of people who get a stem cell injection during ACL surgery to those who get the traditional surgery. Follow-ups will measure recovery progress.

Eligible Conditions

Anterior Cruciate Ligament Tears

BioACL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessing functional movement using Functional Testing Algorithm

BioACL Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of care ACL reconstructive surgeryExperimental Treatment1 Intervention

This is the control group of this study. These participants will receive standard ACL reconstructive surgery without any augmentations.

Group II: ACL reconstruction utilizing stump-derived mesenchymal stem cellsExperimental Treatment2 Interventions

This is the test group of this study. These participants will receive the augmented ACL reconstruction treatment involving extraction and injection of mesenchymal stem cells. Stem cell tissue will be harvested from each participant using the GraftNet device intraoperatively. During the intra-articular preparation phase of the reconstruction, the stem cell tissue will be applied to the ACL graft using a bovine collagen matrix.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ACL reconstruction

2019

N/A

~480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

FloridaOTHER

9 Previous Clinical Trials

1,034 Total Patients Enrolled

Andrews Research & Education FoundationLead Sponsor

18 Previous Clinical Trials

829 Total Patients Enrolled

1 Trials studying Anterior Cruciate Ligament Tear

40 Patients Enrolled for Anterior Cruciate Ligament Tear

Adam Anz, MDPrincipal InvestigatorOrthopedic Surgeon

7 Previous Clinical Trials

320 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I be considered as a participant in this trial?

"To meet the qualifications for this clinical trial, individuals must have an acl tear and be between 14 and 50 years old. The research team is searching to enrol approximately 50 patients."

Answered by AI

Does the trial accept applicants who are fifty years of age or older?

"According to this clinical trial's requirements, the lower age limit for enrollment is 14 years old and the upper age limit is 50."

Answered by AI

How many individuals have taken part in this clinical research thus far?

"Aye, the information posted on clinicaltrials.gov declares that this medical experiment is actively searching for participants. This trial was debuted on August 16th 2022 and has been updated most recently on October 12th 2022; it requires 50 recruits from a single site."

Answered by AI

Are there any available openings for individuals to join this research program?

"Affirmative. According to the data on clinicaltrials.gov, this medical research project commenced its recruitment process on August 16th 2022 and was recently updated. The investigators wish to enroll 50 participants from a single site."

Answered by AI

Recent research and studies

The American Journal of Sports MedicineJournal

Acceleration of Tendon-bone Healing of Anterior Cruciate Ligament Graft Using Autologous Ruptured Tissue

Matsumoto, Tomoyuki, Seiji Kubo, Ken Sasaki, Yohei Kawakami, Shinya Oka, Hiroshi Sasaki, Koji Takayama, et al.. 2012. “Acceleration of Tendon-bone Healing of Anterior Cruciate Ligament Graft Using Autologous Ruptured Tissue”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546512439026.

Journal of Science and Medicine in SportJournal

Incidence of Anterior Cruciate Ligament Injury and Other Knee Ligament Injuries: A National Population-based Study

Gianotti, Simon M., Stephen W. Marshall, Patria A. Hume, and Lorna Bunt. 2009. “Incidence of Anterior Cruciate Ligament Injury and Other Knee Ligament Injuries: A National Population-based Study”. Journal of Science and Medicine in Sport. Elsevier BV. doi:10.1016/j.jsams.2008.07.005.

BiomaterialsJournal

Tendon Graft Revitalization Using Adult Anterior Cruciate Ligament (acl)-derived CD34+ Cell Sheets for ACL Reconstruction

Mifune, Yutaka, Tomoyuki Matsumoto, Koji Takayama, Satoshi Terada, Naosumi Sekiya, Ryosuke Kuroda, Masahiro Kurosaka, Freddie H. Fu, and Johnny Huard. 2013. “Tendon Graft Revitalization Using Adult Anterior Cruciate Ligament (acl)-derived CD34+ Cell Sheets for ACL Reconstruction”. Biomaterials. Elsevier BV. doi:10.1016/j.biomaterials.2013.04.013.

Journal of the American Academy of Orthopaedic SurgeonsJournal