drugset
Drugs / Iltamiocel
last change Sep 2026 re-read 3 minutes ago

Iltamiocel

also known as AMDC-USR · Autologous Muscle Derived Cells for Urinary Sphincter Repair · Autologous Muscle-Derived Cells (AMDC)

Cell therapy

Developed for
female stress incontinence
Investigated by
Cook MyoSite

Trials 6

today NCT03997318 · Ph 3 NCT05776277 · Ph 3 NCT03104517 · Ph 3 NCT01893138 · Ph 3 NCT01600755 · Ph 1/2 NCT01382602 · Ph 3
2012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT01600755 Mar 2013 → Oct 2021 — Cook MyoSite Completed No outcome recorded
Phase 35 trials · 1 missed
Phase 3 NCT03997318 Jun 2025 → Jun 2026 female stress incontinence Cook MyoSite Withdrawn No outcome recorded Stop: Enrollment
Phase 3 NCT05776277 Mar 2024 → Dec 2026 expected — Cook MyoSite Active not recruiting No outcome recorded
Phase 3 NCT03104517 Apr 2019 → Sep 2026 overdue female stress incontinence Cook MyoSite Active not recruiting No outcome recorded
Phase 3 NCT01893138 Nov 2013 → Nov 2019 female stress incontinence Cook MyoSite Completed Missed primary
Phase 3 NCT01382602 Nov 2011 → Feb 2016 female stress incontinence Cook MyoSite Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2025-03-12 Cook MyoSite Iltamiocel Platform: Publications List cookmyosite.com ↗

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as iltamiocel ClinicalTrials.gov intervention name — accepted as the source's own label NCT03104517 ↗
3

NCT01600755 ↗

NCT05776277 ↗

NCT01893138 ↗
Known as AMDC-USR “Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) involves a medical procedure in which a participant's own muscle cells are...” NCT03104517 ↗
2

NCT01382602 ↗

NCT03997318 ↗
Known as Autologous Muscle Derived Cells for Urinary Sphincter Repair “This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress...” NCT01382602 ↗
Known as Autologous Muscle-Derived Cells (AMDC) “The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own...” NCT01600755 ↗
Modality Cell therapy “an investigational cellular therapy of autologous muscle-derived cells” PMID 37144409 ↗ May 2023
Route Other “transurethral intrasphincteric injection” NCT01382602 ↗