Primary Ovarian Insufficiency (Poi)Phase 1/2HS_SW01NCT07551895

Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Primary Ovarian Insufficiency

A Phase 1/2 study testing HS_SW01 cells injection in people with Primary Ovarian Insufficiency (Poi), run by Shenzhen Huishan Biotechnology Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

Search all trials

Trial summary

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of human umbilical cord mesenchymal stem cell injection (HS_SW01 cells injection) in patients with Primary Ovarian Insufficiency (POI). Read more about this study

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Primary Ovarian Insufficiency (Poi)
What is being tested?: HS_SW01 cells injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: No sites listed yet
Study dates: 15 Apr 2026to 31 Dec 2027
Phase: Phase 1/2
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 18 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

Voluntarily sign the informed consent form;
Age ≥18 to <40 years, with oligomenorrhea or amenorrhea >4 months;
Serum baseline FSH >25 U/L (at least two measurements, interval >4 weeks);
Have received stable standard treatment for POI, such as ≥3 months of standardized hormone replacement therapy (HRT) with stable hormone levels;
No fertility requirement and adherence to strict contraception.

Who cannot join

Individuals with childbearing plans or those who are pregnant.
Genetic disorders, chromosomal abnormalities, or genetic defects known to cause premature ovarian insufficiency (POI).
Endocrine disorders affecting ovarian function, including polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, diabetes mellitus, and abnormalities of thyroid or adrenal function.
Presence of breast, uterine, or ovarian tumors; known or suspected sex hormone-dependent malignancies; or any other benign or malignant tumors.
Primary amenorrhea.
Uterine malformations.

Show all 20Show fewer

Iatrogenic or drug-induced ovarian insufficiency.
Uncontrolled acute or chronic gynecological inflammation (including endometritis, etc.).
Bilateral endometrial thickness ≤8 mm after moderate-to-severe intrauterine adhesion surgery.
Complicated with endometriosis.
Severe functional impairment of major organs or coagulation disorders.
Active venous or arterial thromboembolic disease within the past 6 months.
Severe hepatic or renal insufficiency, etc.
Vaccination with live or live-attenuated vaccines within 2 months prior to enrollment.
Prior treatment with mesenchymal stem cells less than 3 months before enrollment.
Uncontrolled hypertension (>150/100 mmHg).
Any of the following conditions within 3 months prior to enrollment:
Major trauma or major surgery (including joint surgery), or anticipated need for major surgery during the study period, which in the investigator's opinion poses unacceptable risk to the participant;
Receipt of plasma exchange or extracorporeal photopheresis;
Participation in any other interventional clinical trial.

About this study

Official title: A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Primary Ovarian Insufficiency

Participants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.

Read the detailed description

This trial consists of a Phase I dose-escalation stage and a Phase II dose-expansion stage. Phase I is a randomized, double-blind, placebo-controlled design in which all participants receive background therapy plus a single intravenous infusion of HS_SW01 cells injection (1.0×10^6 cells/kg, 2.0×10^6 cells/kg, 3.0×10^6 cells/kg) or placebo, with 4-7 participants per dose group. A "3+3" dose-escalation design is used to evaluate safety, tolerability, pharmacokinetics, and immunogenicity across the three dose groups. In Phase II, the optimal biological dose (OBD) identified from the Phase I escalation study will serve as the recommended Phase II dose (RP2D) to preliminarily assess efficacy while continuing safety monitoring, providing a basis for subsequent clinical trials.

Eligible participants are patients with POI aged ≥18 to <40 years who meet all inclusion criteria and none of the exclusion criteria.

Conditions: Primary Ovarian Insufficiency (Poi)
Being tested: HS_SW01 cells injection
Keywords: Primary Ovarian Insufficiency, MSC
Medical subject headings: Primary Ovarian Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HS_SW01 cells injectionDrug
A single dose of 1×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.
HS_SW01 cells injectionDrug
A single dose of 2×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.
HS_SW01 cells injectionDrug
A single dose of 3×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.

Study groups in NCT07551895
Study group	Role	What they receive
Low dose group	Experimental	intravenous inject MSCs Receives: Drug: HS_SW01 cells injection
Medium dose group	Experimental	intravenous inject MSCs Receives: Drug: HS_SW01 cells injection
High dose group	Experimental	intravenous inject MSCs Receives: Drug: HS_SW01 cells injection

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of DLT
Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.
Measured: Within 28 Days

Secondary outcomes (7)

Changes of the Anti-Müllerian hormone (AMH) serum level from baseline.
Evaluate the AMH serum level by blood sampling at baseline and at Week 4, Week 12 and Week 24 after administration to assess changes of the Anti-Müllerian hormone (AMH) serum level from baseline.
Measured: Baseline, Week 4, Week 12, Week 24
Changes of the Follicle Stimulating Hormone (FSH) serum level from baseline.
Evaluate the FSH serum level by blood sampling at baseline and at Week 4, Week 12 and Week 24 after administration to assess changes of the Follicle Stimulating Hormone (FSH) serum level from baseline.
Measured: Baseline, Week 4, Week 12, Week 24
Changes of Luteinizing Hormone (LH) serum level from baseline.
Evaluate the LH serum level by blood sampling at baseline and at Week 4, Week 12 and Week 24 after administration to assess changes of Luteinizing Hormone (LH) serum level from baseline.
Measured: Baseline, Week 4, Week 12, Week 24
Changes of the Estradiol (E2) serum level from baseline.
Evaluate the E2 serum level by blood sampling at baseline and at Week 4, Week 12 and Week 24 after administration to assess changes of the Estradiol (E2) serum level from baseline.
Measured: Baseline, Week 4, Week 12, Week 24
Changes of the Antral Follicle Counting (AFC) from baseline.
Evaluate the Antral Follicle Counting (AFC) by sonography at baseline and at Week 4, Week 12 and Week 24 after administration to assess Changes of the Antral Follicle Counting (AFC) from baseline .
Measured: Baseline, Week 4, Week 12, Week 24
Changes of the Ovarian Volume (OV) from baseline.
Evaluate the Ovarian Volume (OV) by sonography at baseline and at Week 4, Week 12 and Week 24 after administration to assess Changes of the Ovarian Volume (OV) from baseline.
Measured: Baseline, Week 4, Week 12, Week 24
Changes of the menstrual function indicators from baseline.
Menstrual function indicators will be recorded via patient diaries or visit questionnaires to evaluate the recovery of menstruation following treatment. The form includes the date of menstrual onset, duration of menstruation (in days), menstrual regularity (regular/irregular; regular defined as cycle fluctuation ≤7 days), and associated symptoms (dysmenorrhea/other, with descriptive notes).Menstrual blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC), which records, for each menstrual cycle, the type and number of sanitary products used daily, the frequency of clots passed into the toilet, and the total menstrual blood loss (in mL).
Menstrual function recovery is defined as meeting all of the following criteria:
（1）At least two consecutive cycles of menstrual bleeding after treatment discontinuation;（2）Cycle length restored to 21-35 days;（3）Menstrual blood volume returned to pre-illness levels compared with the subject's own baseline.
Measured: Up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202631 Dec 2027

First posted27 Apr 2026
Study start15 Apr 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Ovarian Insufficiency (Poi)Studies of the same condition, open and under way.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 21 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07551895
Sponsor's protocol ID: HS_SW01-POI
Acronym: HS_SW01
Status last verified: Apr 2026
First submitted: 12 Apr 2026
Last updated: 27 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
RecruitingPhase 3
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Premature Ovarian Insufficiency
RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
Not yet recruitingEarly Phase 1
Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress
Premature Ovarian Insufficiency

All Primary Ovarian Insufficiency (Poi) trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Primary Ovarian Insufficiency
ClinicalTrials.gov ID: NCT07551895
Acronym / sponsor ID: HS_SW01 / HS_SW01-POI
Conditions: Primary Ovarian Insufficiency (Poi)
Keywords: Primary Ovarian Insufficiency, MSC
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 21 participants (estimated)
Lead sponsor: Shenzhen Huishan Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Southern Medical University, China
Study start: 15 Apr 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 27 Apr 2026 (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.

Detailed description

Eligible participants are patients with POI aged ≥18 to <40 years who meet all inclusion criteria and none of the exclusion criteria.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Low dose group	Experimental	Drug: HS_SW01 cells injectionintravenous inject MSCs
Medium dose group	Experimental	Drug: HS_SW01 cells injectionintravenous inject MSCs
High dose group	Experimental	Drug: HS_SW01 cells injectionintravenous inject MSCs

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Voluntarily sign the informed consent form;
Age ≥18 to <40 years, with oligomenorrhea or amenorrhea >4 months;
Serum baseline FSH >25 U/L (at least two measurements, interval >4 weeks);
Have received stable standard treatment for POI, such as ≥3 months of standardized hormone replacement therapy (HRT) with stable hormone levels;
No fertility requirement and adherence to strict contraception.

Key exclusion criteria (20 listed)

Individuals with childbearing plans or those who are pregnant.
Genetic disorders, chromosomal abnormalities, or genetic defects known to cause premature ovarian insufficiency (POI).
Endocrine disorders affecting ovarian function, including polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, diabetes mellitus, and abnormalities of thyroid or adrenal function.
Presence of breast, uterine, or ovarian tumors; known or suspected sex hormone-dependent malignancies; or any other benign or malignant tumors.
Primary amenorrhea.

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
HS_SW01 cells injectionA single dose of 1×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.	Drug	Low dose group
HS_SW01 cells injectionA single dose of 2×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.	Drug	Medium dose group
HS_SW01 cells injectionA single dose of 3×10^6 cells/kg of HS_SW01 cells injection will be given by intravenous infusion.	Drug	High dose group

Primary outcome

The incidence of DLT
Time frame: Within 28 Days
Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.

7 secondary outcomes

Changes of the Anti-Müllerian hormone (AMH) serum level from baseline.
Time frame: Baseline, Week 4, Week 12, Week 24
Changes of the Follicle Stimulating Hormone (FSH) serum level from baseline.
Time frame: Baseline, Week 4, Week 12, Week 24
Changes of Luteinizing Hormone (LH) serum level from baseline.
Time frame: Baseline, Week 4, Week 12, Week 24
Changes of the Estradiol (E2) serum level from baseline.
Time frame: Baseline, Week 4, Week 12, Week 24
Changes of the Antral Follicle Counting (AFC) from baseline.
Time frame: Baseline, Week 4, Week 12, Week 24
Changes of the Ovarian Volume (OV) from baseline.
Time frame: Baseline, Week 4, Week 12, Week 24
Changes of the menstrual function indicators from baseline.
Time frame: Up to Week 24

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 27 Apr 2026.
Individual participant dataSharing planned: No

Related trials for Primary Ovarian Insufficiency (Poi)

RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
Not yet recruitingPhase 1
Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
RecruitingPhase 3
Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency
Premature Ovarian Insufficiency
RecruitingObservational study
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
Not yet recruitingEarly Phase 1
Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress
Premature Ovarian Insufficiency

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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HS_SW01 cells injection in people with Primary Ovarian Insufficiency (Poi), run by Shenzhen Huishan Biotechnology Co., Ltd..

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 5 inclusion and 20 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: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The incidence of DLT (time frame: Within 28 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07551895.

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 27 Apr 2026.