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Meniscus TearPhase 1/2NCT05560477

Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

A Phase 1/2 study testing AM3101 in people with Meniscus Tear, run by University of Cincinnati at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this clinical trial is to assess the safety and efficacy of AM3101 to facilitate meniscal repair and reduce the incidence of non-healing complications and morbidities associated with a failed meniscal repair. This is a prospective, randomized, controlled, double-blinded, multi-center study. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Meniscus Tear
What is being tested?
AM3101
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
3 sitesUnited States
Study dates
26 Apr 2023to 30 Sep 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male or female ≥ 18 and ≤ 40 years old at time of screening.
  • MRI evidence of ACL plus meniscus tear, or isolated meniscus tear.
  • Body mass index (BMI) ≤ 40 kg/m2.
  • Liver and kidney function panels within normal ranges at time of screening
  • Willing and able to comply with the study procedures and visit schedule, and able to follow oral and written instructions.
  • Willing and able to sign an IRB approved informed consent

Who cannot join

  • Have any concomitant ligament injury requiring surgical repair or reconstruction other than the ACL.
  • Have a history of previous meniscus injury that currently needs to be treated or has been treated surgically.
  • Have evidence of arthritis ≥ Grade III (Outerbridge classification) in the affected compartment or greater than Kellgren Lawrence Grade 3.
  • Elevated AST or ALT liver enzymes at time of screening
  • Pregnant or nursing mothers, or women planning on getting pregnant during the time they will be participating in the study.
  • Known drug or alcohol dependence currently or within the last year.
Show all 11Show fewer
  • Participating concurrently in another clinical study or have participated in a clinical study within the last 90 days, or intend to during the course of the study.
  • Any medical condition or other circumstances that might interfere with the ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate postoperative rehabilitation.
  • Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the investigational product's safety and efficacy.
  • Known allergic reaction to simvastatin.
  • Patients currently taking simvastatin, or any other drug that is within the statin drug classification family.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Oregon Health & Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Prospective, Randomized, Controlled, Double-Blinded, Multi-Center, Phase 1/2b Study to Evaluate the Safety and Efficacy of AM3101 to Augment Meniscal Healing

The purpose of this clinical trial is to assess the safety and efficacy of AM3101 to facilitate meniscal repair and reduce the incidence of non-healing complications and morbidities associated with a failed meniscal repair. This is a prospective, randomized, controlled, double-blinded, multi-center study.

Read the detailed description

Primary Efficacy Objective: Assess the efficacy of AM3101 by evaluating the integrity of repaired meniscal tissue assessed via MRI at 12 months following injection with AM3101 as compared to the integrity of meniscal tissue at 12 months in the control group injected with a saline solution (placebo).

Primary Safety Objective: Assess the safety of AM3101 by evaluating the incidence of individual adverse events and comparing these adverse event rates to incidence rates for the control group injected with a saline solution (placebo).

Secondary Objective: Assess and compare functional outcomes in patients receiving AM3101 following meniscal repair to functional outcomes in the control group injected with a saline solution (placebo).

Conditions
Meniscus Tear
Being tested
AM3101, Saline Placebo
Keywords
meniscal repair, complications, morbidities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AM3101Drug

    Injectable drug product.

  • Saline PlaceboDrug

    2 mL 0.9% normal saline

Study groups in NCT05560477
Study groupRoleWhat they receive
Treated with repair and AM3101ExperimentalSyringe containing AM3101 for injection.
Receives: Drug: AM3101
Treated with repair and 0.9% sodium chloride (saline)Placebo comparatorSyringe containing commercially available 0.9% sodium chloride for injection.
Receives: Drug: Saline Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Healing Assessed via MRI

    Presence or absence of healing assessed via MRI

    Measured: 12 months

  2. Incidence of Adverse Events

    Incidence of adverse events in subjects receiving AM3101 following meniscal repair, as compared to subjects undergoing meniscal repair and injected with a saline solution (placebo).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start26 Apr 2023
  3. Primary completion30 Sep 2026
  4. Study completion30 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, controlled, double-blinded, multi-center study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05560477
Sponsor's protocol ID
Protocol Number: SM17091
Other IDs
UC IRB Number: 2019-0468
Status last verified
Oct 2026
First submitted
23 Sep 2022
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: A public-use version of the dataset will be constructed with contents to be determined by the study PI. Copies of the public-use version of the dataset will be housed at the University of Cincinnati on a secure server along with suitable documentation of this dataset. The public-use version of the dataset will be exported by CRF in one or more files in simple, widely-accessible formats, e.g., .xls, .csv, and/or SAS datasets. Documentation will be in .pdf files.

Publications

  • Nepple JJ, Dunn WR, Wright RW. Meniscal repair outcomes at greater than five years: a systematic literature review and meta-analysis. J Bone Joint Surg Am. 2012 Dec 19;94(24):2222-7. doi: 10.2106/JBJS.K.01584.

    PubMed 23318612

  • Xu H, Bouta EM, Wood RW, Schwarz EM, Wang Y, Xing L. Utilization of longitudinal ultrasound to quantify joint soft-tissue changes in a mouse model of posttraumatic osteoarthritis. Bone Res. 2017 Jun 13;5:17012. doi: 10.1038/boneres.2017.12. eCollection 2017.

    PubMed 28638676

  • Proulx ST, Kwok E, You Z, Papuga MO, Beck CA, Shealy DJ, Ritchlin CT, Awad HA, Boyce BF, Xing L, Schwarz EM. Longitudinal assessment of synovial, lymph node, and bone volumes in inflammatory arthritis in mice by in vivo magnetic resonance imaging and microfocal computed tomography. Arthritis Rheum. 2007 Dec;56(12):4024-37. doi: 10.1002/art.23128.

    PubMed 18050199

  • Fukui T, Ii M, Shoji T, Matsumoto T, Mifune Y, Kawakami Y, Akimaru H, Kawamoto A, Kuroda T, Saito T, Tabata Y, Kuroda R, Kurosaka M, Asahara T. Therapeutic effect of local administration of low-dose simvastatin-conjugated gelatin hydrogel for fracture healing. J Bone Miner Res. 2012 May;27(5):1118-31. doi: 10.1002/jbmr.1558.

    PubMed 22275312

  • Oka S, Matsumoto T, Kubo S, Matsushita T, Sasaki H, Nishizawa Y, Matsuzaki T, Saito T, Nishida K, Tabata Y, Kurosaka M, Kuroda R. Local administration of low-dose simvastatin-conjugated gelatin hydrogel for tendon-bone healing in anterior cruciate ligament reconstruction. Tissue Eng Part A. 2013 May;19(9-10):1233-43. doi: 10.1089/ten.TEA.2012.0325. Epub 2013 Jan 14.

    PubMed 23198912

  • Vos LM, Kuijer R, Huddleston Slater JJ, Bulstra SK, Stegenga B. Inflammation is more distinct in temporomandibular joint osteoarthritis compared to the knee joint. J Oral Maxillofac Surg. 2014 Jan;72(1):35-40. doi: 10.1016/j.joms.2013.08.022. Epub 2013 Nov 6.

    PubMed 24210930

  • Donahue RP, Gonzalez-Leon EA, Hu JC, Athanasiou K. Considerations for translation of tissue engineered fibrocartilage from bench to bedside. J Biomech Eng. 2018 Dec 5;141(7):0708021-07080216. doi: 10.1115/1.4042201. Online ahead of print.

    PubMed 30516244

  • Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006.

    PubMed 21882780

  • Sanders JW, Putnam SD, Frankart C, Frenck RW, Monteville MR, Riddle MS, Rockabrand DM, Sharp TW, Tribble DR. Impact of illness and non-combat injury during Operations Iraqi Freedom and Enduring Freedom (Afghanistan). Am J Trop Med Hyg. 2005 Oct;73(4):713-9.

    PubMed 16222015

  • Hutchinson ID, Moran CJ, Potter HG, Warren RF, Rodeo SA. Restoration of the meniscus: form and function. Am J Sports Med. 2014 Apr;42(4):987-98. doi: 10.1177/0363546513498503. Epub 2013 Aug 12.

    PubMed 23940202

  • Fox AJ, Wanivenhaus F, Burge AJ, Warren RF, Rodeo SA. The human meniscus: a review of anatomy, function, injury, and advances in treatment. Clin Anat. 2015 Mar;28(2):269-87. doi: 10.1002/ca.22456. Epub 2014 Aug 14.

    PubMed 25125315

  • Cox JS, Nye CE, Schaefer WW, Woodstein IJ. The degenerative effects of partial and total resection of the medial meniscus in dogs' knees. Clin Orthop Relat Res. 1975;(109):178-83. doi: 10.1097/00003086-197506000-00026.

    PubMed 1173359

  • Kadam UT, Blagojevic M, Belcher J. Statin use and clinical osteoarthritis in the general population: a longitudinal study. J Gen Intern Med. 2013 Jul;28(7):943-9. doi: 10.1007/s11606-013-2382-8. Epub 2013 Mar 8.

    PubMed 23471638

  • Gupta S, Del Fabbro M, Chang J. The impact of simvastatin intervention on the healing of bone, soft tissue, and TMJ cartilage in dentistry: a systematic review and meta-analysis. Int J Implant Dent. 2019 Apr 9;5(1):17. doi: 10.1186/s40729-019-0168-4.

    PubMed 30963362

  • Zhang S, Matsushita T, Kuroda R, Nishida K, Matsuzaki T, Matsumoto T, Takayama K, Nagai K, Oka S, Tabata Y, Nagamune K, Kurosaka M. Local Administration of Simvastatin Stimulates Healing of an Avascular Meniscus in a Rabbit Model of a Meniscal Defect. Am J Sports Med. 2016 Jul;44(7):1735-43. doi: 10.1177/0363546516638342. Epub 2016 Apr 11.

    PubMed 27159292

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AM3101 in people with Meniscus Tear, run by University of Cincinnati at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healing Assessed via MRI (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05560477, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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