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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT05560477
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Meniscus Tear

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • AM3101 — DRUG
    Injectable drug product.
  • Saline Placebo — DRUG
    2 mL 0.9% normal saline

Study Details

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.

Key Dates

Start date
Apr 26, 2023
Status verified
May 2025
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treated with repair and AM3101
    Syringe containing AM3101 for injection.
  • Placebo Comparator: Treated with repair and 0.9% sodium chloride (saline)
    Syringe containing commercially available 0.9% sodium chloride for injection.

Primary Outcome Measure

Healing Assessed via MRI [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45267
Kimberly A Hasselfeld
[email protected]
513-558-1933
Rebekah West
[email protected]
513-558-1933
Brian M Grawe, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Peter Levin
[email protected]
216-904-5185
Jacob Calcei, MD (PRINCIPAL_INVESTIGATOR)
James Voos, MD (SUB_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Albert Yim
[email protected]
503-494-5164
Jacqueline Brady, MD (PRINCIPAL_INVESTIGATOR)
Andrea Herzka, MD (SUB_INVESTIGATOR)

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