NCT07101484 - A Study of GD007 (Human iPSC-Exosome Liquid Dressing) for Safety and Dose-Finding in Moderate-Severe Intrauterine Adhesions | Biotech Hunter

Enrollment

29

Participants

Timeline

Start Date

May 4, 2025

Primary Completion Date

May 30, 2026

Study Completion Date

December 31, 2026

Conditions

Moderate-Severe Intrauterine Adhesions

Interventions

DRUG

GD007 Low-dose drug group

"o Eligible patients who provide informed consent will receive:~* First exosome perfusion: 24 hours post-operatively~* Subsequent perfusions: Every 3 days (total 3 perfusions)"

DRUG

GD007 Mid-dose drug group

"* Patients diagnosed with moderate-to-severe intrauterine adhesions (IUA) will undergo standard hysteroscopic adhesiolysis.~* Eligible patients who provide informed consent will receive:~ * First exosome perfusion: 24 hours post-operatively~ * Subsequent perfusions: Every 3 days (total 3 perfusions)"

DRUG

GD007 High-dose drug group

"* Patients diagnosed with moderate-to-severe intrauterine adhesions (IUA) will undergo standard hysteroscopic adhesiolysis.~* Eligible patients who provide informed consent will receive:~ * First exosome perfusion: 24 hours post-operatively~ * Subsequent perfusions: Every 3 days (total 3 perfusions)"

DRUG

GD007 Blank Control drug Group

"* Patients diagnosed with moderate-to-severe intrauterine adhesions (IUA) will undergo standard hysteroscopic adhesiolysis.~* Eligible patients who provide informed consent will receive:~ * First exosome perfusion: 24 hours post-operatively~ * Subsequent perfusions: Every 3 days (total 3 perfusions)"

Trial Locations (1)

210000

Clinical Center o Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University, Nanjing