Moderate-Severe Intrauterine AdhesionsGD007NCT07101484
A Study of GD007 (Human iPSC-Exosome Liquid Dressing) for Safety and Dose-Finding in Moderate-Severe Intrauterine Adhesions
A study testing GD007 Low-dose drug group, GD007 Mid-dose drug group and GD007 High-dose drug group in people with Moderate-Severe Intrauterine Adhesions, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Moderate-Severe Intrauterine Adhesions
- What is being tested?
- GD007 Low-dose drug group, GD007 Mid-dose drug group and GD007 High-dose drug group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Active Infections
- o Acute pelvic inflammatory disease or vaginitis
- Uterine Abnormalities
- History of uterine artery embolization
- Submucosal fibroids (>2 cm)
- Adenomyosis with uterine size >8-week gestation
Show all 25Show fewer
- Neoplastic Conditions
- Malignancies
- Endometrial hyperplasia (with/without atypia)
- Contraindications
- o Hypersensitivity to hyaluronic acid gel
- Hormonal Medications
- Chronic steroid use
- High-dose hormone therapy (>8 mg/day estrogen/progestin within 1 month)
- Hematologic Disorders
- Thrombocytopenia (platelets <50×10⁹/L)
- Coagulopathy (aPTT >1.5×ULN)
- Systemic Diseases
- Uncontrolled diabetes (HbA1c >7%)
- Severe cardiovascular disease (NYHA Class III/IV)
- Life-threatening comorbidities
- Clinical Trial Participation
- Enrollment in other interventional trials within 3 months
- Recent drug trials (<5 half-lives from last dose)
- Investigator's Discretion o Any condition deemed unsuitable for participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Clinical Center o Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
About this study
Official title: 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.
Read more
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:
- 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
- Enhanced pharmaceutical suitability:
- Clonal expansion ensures product homogeneity and manufacturing reproducibility.
- Simplified quality control metrics compared to heterogeneous MSC-Exo.
- Genetic engineering compatibility:
- Amenable to precision modification for targeted therapeutic enhancement.
- 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:
- Establish preliminary safety profiles
- Explore therapeutic efficacy signals
- 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.
Read the detailed description
1、Study Objectives
- Primary Objective To evaluate the clinical safety of human iPSC-derived exosome liquid dressing (GD007) in patients with moderate-to-severe intrauterine adhesions (IUA).
- 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
- 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
- Conditions
- Moderate-Severe Intrauterine Adhesions
- Being tested
- GD007 Low-dose drug group, GD007 Mid-dose drug group, GD007 High-dose drug group, GD007 Blank Control drug Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GD007 Low-dose drug groupDrug
Also called GD007
- Eligible patients who provide informed consent will receive:
- First exosome perfusion: 24 hours post-operatively
- Subsequent perfusions: Every 3 days (total 3 perfusions)
GD007 Mid-dose drug groupDrug
Also called GD007
- 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)
GD007 High-dose drug groupDrug
Also called GD007
- 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)
GD007 Blank Control drug GroupDrug
Also called GD007
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Low-dose drug group | Experimental | 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) Receives: Drug: GD007 Low-dose drug group |
| Mid-dose drug group | Experimental | * 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) Receives: Drug: GD007 Mid-dose drug group |
| High-dose drug group | Experimental | * 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) Receives: Drug: GD007 High-dose drug group |
| Blank Control drug group | Placebo comparator | * 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) Receives: Drug: GD007 Blank Control drug Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measure: Incidence of severe intolerability after intrauterine perfusion of iPS cell-derived exosome liquid dressing
including:
- Persistent severe nausea/vomiting
- Rash
- Fever
- Acute reproductive tract infections
- Severe abnormal uterine bleeding (non-surgical etiology)
Measured: From Day 1 of GD007 exosome dressing application to 6 months post-treatment
Secondary outcomes (2)
Effectiveness measures: Recurrence rate of intrauterine adhesions (IUA) 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.
Measured: From Day 1 of GD007 exosome dressing application to 6 months post-treatment
Effectiveness measures:Endometrial thickness
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.
Measured: From Day 1 of GD007 exosome dressing application to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start4 May 2025
- Primary completion30 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-Severe Intrauterine AdhesionsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101484
- Sponsor's protocol ID
- IIT_ iPSC-Exosome Liquid Dress
- Other IDs
- 2024-SR-1162
- Acronym
- GD007
- Status last verified
- May 2025
- First submitted
- 26 Jun 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share Study Protocol Approved by the Institutional Ethics Committee and Final Clinical Study Report with Investigator Signatures
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of GD007 (Human iPSC-Exosome Liquid Dressing) for Safety and Dose-Finding in Moderate-Severe Intrauterine Adhesion
- ClinicalTrials.gov ID
- NCT07101484
- Acronym / sponsor ID
- GD007 / IIT_ iPSC-Exosome Liquid Dress
- Conditions
- Moderate-Severe Intrauterine Adhesions
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 4 May 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Enhanced pharmaceutical suitability:
- Clonal expansion ensures product homogeneity and manufacturing reproducibility.
- Simplified quality control metrics compared to heterogeneous MSC-Exo.
- Genetic engineering compatibility:
- Amenable to precision modification for targeted therapeutic enhancement.
- 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:
- Establish preliminary safety profiles
- Explore therapeutic efficacy signals
- 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.
Detailed description
1、Study Objectives
- Primary Objective To evaluate the clinical safety of human iPSC-derived exosome liquid dressing (GD007) in patients with moderate-to-severe intrauterine adhesions (IUA).
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-dose drug group | Experimental | Drug: GD007 Low-dose drug groupLow-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) |
| Mid-dose drug group | Experimental | 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) |
| High-dose drug group | Experimental | 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) |
| Blank Control drug group | Placebo comparator | 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) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1) Demographics
Key exclusion criteria (25 listed)
- Active Infections
- o Acute pelvic inflammatory disease or vaginitis
- Uterine Abnormalities
- Neoplastic Conditions
- Contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GD007 Low-dose drug groupAlso: GD007o Eligible patients who provide informed consent will receive: * First exosome perfusion: 24 hours post-operatively * Subsequent perfusions: Every 3 days (total 3 perfusions) | Drug | Low-dose drug group |
| GD007 Mid-dose drug groupAlso: GD007* 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 | Mid-dose drug group |
| GD007 High-dose drug groupAlso: GD007* 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 | High-dose drug group |
| GD007 Blank Control drug GroupAlso: GD007* 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 | Blank Control drug group |
Primary outcome
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)
2 secondary outcomes
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
Effectiveness measures:Endometrial thickness
Time frame: From Day 1 of GD007 exosome dressing application to 6 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Yes. Share Study Protocol Approved by the Institutional Ethics Committee and Final Clinical Study Report with Investigator Signatures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GD007 Low-dose drug group, GD007 Mid-dose drug group and GD007 High-dose drug group in people with Moderate-Severe Intrauterine Adhesions, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 25 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: enrolling by invitation, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.