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

July 28, 2025 updated by: The First Affiliated Hospital with Nanjing Medical University

A Study of GD007 (Human iPSC-Exosome Liquid Dressing) for Safety and Dose-Finding in Moderate-Severe Intrauterine Adhesion

Intrauterine adhesions (IUA) remain highly prevalent in China, with incidence rates steadily increasing due to the rising number of intrauterine procedures. Literature reports indicate that IUA caused by repeated induced abortions, curettage, postpartum infections, and other intrauterine surgeries occurs in 25%-30% of cases, making it a leading cause of reduced menstrual flow, cyclic abdominal pain, recurrent miscarriage, and secondary infertility, significantly impairing women's reproductive health and overall well-being.

Currently, no effective treatment exists for severe IUA to fully restore fertility and normal menstrual physiology. The commonly used hysteroscopic adhesiolysis (TCRA) has a high recurrence rate of 62.5%, with a post-operative pregnancy success rate of only 22.5%-33.3%. Therefore, there is an urgent clinical need to explore novel therapeutic strategies for severe intrauterine adhesions.

Exosomes derived from induced pluripotent stem cells (iPS-Exo) offer significant advantages over MSC-derived exosomes due to their clonal origin, ensuring superior batch-to-batch consistency and stability. This feature enables more stringent quality control standards and facilitates standardized, scalable production and quality management systems. Compared to mesenchymal stem cells (MSCs) or MSC-derived exosomes, iPS-Exo exhibit multiple superior properties:

  1. Higher potency of bioactive components:

    • As iPSCs represent an earlier differentiation stage than MSCs, iPS-Exo contain elevated levels of functional factors such as TGF-β (anti-inflammatory), BDNF (neurotrophic), and others.

    • Demonstrated biological effects:

      • Anti-apoptosis
      • Inflammation suppression
      • Angiogenesis promotion
      • Fibrosis inhibition
      • Enhanced tissue repair potential

  2. Enhanced pharmaceutical suitability:

    • Clonal expansion ensures product homogeneity and manufacturing reproducibility.
    • Simplified quality control metrics compared to heterogeneous MSC-Exo.

  3. Genetic engineering compatibility:

    o Amenable to precision modification for targeted therapeutic enhancement.

  4. Preclinical efficacy evidence:

    • Neuroprotection: Superior to MSC-Exo in mitigating neuronal damage induced by oxygen-glucose deprivation and hydrogen peroxide-induced oxidative stress.
    • Epilepsy models: Significant reduction in seizure frequency/severity and decreased cerebral IL-6/TNF-α levels in treated mice.

    • Stroke models: Intravenous administration:

      • Suppressed Th1/Th17 immune responses post-ischemia
      • Increased Treg cell proportion
      • Modulated immune microenvironment
      • Reduced infarct volume and improved motor function
      • Enhanced survival rates Compared to small-molecule drugs or MSC-Exo with limited mechanisms, iPS-Exo demonstrate broader therapeutic potential for ischemic stroke, drug-resistant epilepsy, and other disorders. However, their application in treating endometrial damage from intrauterine adhesions (IUA) remains unexplored to date.

Goodain (Beijing) Pharmaceutical Technology Co., Ltd., a biotechnology company specializing in induced pluripotent stem cells (iPSCs) and exosome technologies, holds GMP laboratory certification. The company has independently developed clinical-grade iPSC-derived exosomes (iPS-Exo), which have been investigated in four investigator-initiated exploratory clinical trials across different indications, with no reported adverse events (AEs) or serious adverse events (SAEs) to date.

Preclinical Rationale

Our research team previously conducted preclinical studies using umbilical cord mesenchymal stem cell-derived exosomes (MSC-Exo) in a rat model of intrauterine adhesions (IUA). Results demonstrated that:

• Intrauterine perfusion of MSC-Exo significantly promoted:

  • Endometrial regeneration in mechanically injured rats
  • Increased endometrial gland density
  • Enhanced cellular proliferation
  • Higher embryo implantation rates These findings support the translational potential of exosome-based therapies for IUA.

Study Objective

Building on this preclinical evidence, we propose the first-in-human safety evaluation of clinical-grade iPS-Exo for moderate-to-severe IUA. This study aims to:

  1. Establish preliminary safety profiles
  2. Explore therapeutic efficacy signals

  3. Address the unmet clinical need in severe IUA management Key Advantages

    • Regulatory-ready: GMP-certified production ensures batch consistency.
    • Clinical precedence: Favorable safety data from prior exploratory trials.
    • Mechanistic validation: Proven endometrial repair effects in animal models.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

1、Study Objectives

  1. Primary Objective To evaluate the clinical safety of human iPSC-derived exosome liquid dressing (GD007) in patients with moderate-to-severe intrauterine adhesions (IUA).
  2. Secondary Objectives To assess the IUA recurrence rate within 6 months post-treatment. To investigate endometrial thickness improvement as a marker of endometrial regeneration.

2、Study Design: Single-center, prospective, open-label 3、Study Procedures IUA Treatment Protocol 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)

Follow-up hysteroscopy at 1 month to assess adhesion recurrence:

If adhesions recur: Repeat adhesiolysis (Step 1) followed by another 3-perfusion cycle (24h post-op)

Monthly follow-up for 6 months to monitor:

  • Adverse events (per CTCAE v5.0)

  • Endometrial thickness (transvaginal ultrasound) Fertility Management IVF/ICSI:Embryo transfer performed per standard protocols after completing exosome therapy Endometrial preparation and transfer procedures follow institutional SOPs Natural conception:Ultrasound-guided ovulation monitoring + timed intercourse Detailed documentation of clinical pregnancy outcomes 4、 Patient Selection Criteria Inclusion Criteria 1) Demographics

    • Females aged 20-40 years with fertility desire 2) Diagnostic Confirmation
    • Hysteroscopically confirmed moderate-to-severe intrauterine adhesions (IUA) *(Per 2015 Chinese IUA Scoring System: Moderate=9-18 points; Severe=19-28 points)* 3) Surgical Eligibility
    • Indicated for hysteroscopic surgery without contraindications 4) Ovarian Function
    • Normal ovarian reserve (AMH ≥1.1 ng/mL or AFC ≥5) 5) Consent

    • Voluntary participation with signed informed consent Exclusion Criteria

      1. Active Infections

    • Acute pelvic inflammatory disease or vaginitis 2. Uterine Abnormalities
    • History of uterine artery embolization
    • Submucosal fibroids (>2 cm)
    • Adenomyosis with uterine size >8-week gestation 3. Neoplastic Conditions
    • Malignancies
    • Endometrial hyperplasia (with/without atypia) 4. Contraindications
    • Hypersensitivity to hyaluronic acid gel 5. Hormonal Medications
    • Chronic steroid use
    • High-dose hormone therapy (>8 mg/day estrogen/progestin within 1 month) 6. Hematologic Disorders
    • Thrombocytopenia (platelets <50×10⁹/L)
    • Coagulopathy (aPTT >1.5×ULN) 7. Systemic Diseases
    • Uncontrolled diabetes (HbA1c >7%)
    • Severe cardiovascular disease (NYHA Class III/IV)
    • Life-threatening comorbidities 8. Clinical Trial Participation
    • Enrollment in other interventional trials within 3 months
    • Recent drug trials (<5 half-lives from last dose) 9. Investigator's Discretion
    • Any condition deemed unsuitable for participation

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Clinical Center o Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1) Demographics

    • Females aged 20-40 years with fertility desire 2) Diagnostic Confirmation
    • Hysteroscopically confirmed moderate-to-severe intrauterine adhesions (IUA) *(Per 2015 Chinese IUA Scoring System: Moderate=9-18 points; Severe=19-28 points)* 3) Surgical Eligibility
    • Indicated for hysteroscopic surgery without contraindications 4) Ovarian Function
    • Normal ovarian reserve (AMH ≥1.1 ng/mL or AFC ≥5) 5) Consent
    • Voluntary participation with signed informed consent

Exclusion Criteria:

  1. Active Infections

    o Acute pelvic inflammatory disease or vaginitis

  2. Uterine Abnormalities

    • History of uterine artery embolization
    • Submucosal fibroids (>2 cm)
    • Adenomyosis with uterine size >8-week gestation

  3. Neoplastic Conditions

    • Malignancies
    • Endometrial hyperplasia (with/without atypia)

  4. Contraindications

    o Hypersensitivity to hyaluronic acid gel

  5. Hormonal Medications

    • Chronic steroid use
    • High-dose hormone therapy (>8 mg/day estrogen/progestin within 1 month)

  6. Hematologic Disorders

    • Thrombocytopenia (platelets <50×10⁹/L)
    • Coagulopathy (aPTT >1.5×ULN)

  7. Systemic Diseases

    • Uncontrolled diabetes (HbA1c >7%)
    • Severe cardiovascular disease (NYHA Class III/IV)
    • Life-threatening comorbidities

  8. Clinical Trial Participation

    • Enrollment in other interventional trials within 3 months
    • Recent drug trials (<5 half-lives from last dose)
  9. Investigator's Discretion o Any condition deemed unsuitable for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-dose drug group

Low-dose Intervention Group for moderate-to-severe intrauterine adhesions

  • 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 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)
Other Names:
  • GD007
Experimental: 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 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)
Other Names:
  • GD007
Experimental: 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 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)
Other Names:
  • GD007
Placebo Comparator: 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)
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)
Other Names:
  • GD007

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Measure: Incidence of severe intolerability after intrauterine perfusion of iPS cell-derived exosome liquid dressing
Time Frame: From Day 1 of GD007 exosome dressing application to 6 months post-treatment

including:

  • Persistent severe nausea/vomiting
  • Rash
  • Fever
  • Acute reproductive tract infections
  • Severe abnormal uterine bleeding (non-surgical etiology)
From Day 1 of GD007 exosome dressing application to 6 months post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness measures: Recurrence rate of intrauterine adhesions (IUA) post-treatment
Time Frame: From Day 1 of GD007 exosome dressing application to 6 months post-treatment
Recurrence rate of intrauterine adhesions (IUA) post-treatment: The rate of IUA recurrence detected by hysteroscopy after the first treatment with iPS cell-derived exosome liquid dressing following initial adhesiolysis.
From Day 1 of GD007 exosome dressing application to 6 months post-treatment
Effectiveness measures:Endometrial thickness
Time Frame: From Day 1 of GD007 exosome dressing application to 6 months post-treatment
Endometrial thickness: Change in endometrial thickness (measured by ultrasound on the day of HCG transformation) before and after intrauterine perfusion of iPS cell-derived exosomes.
From Day 1 of GD007 exosome dressing application to 6 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT_ iPSC-Exosome Liquid Dress
  • 2024-SR-1162 (Other Identifier: Jiangsu Provincial People's Hospital EC Approval Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Share Study Protocol Approved by the Institutional Ethics Committee and Final Clinical Study Report with Investigator Signatures

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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