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Phase 1 UC-MSC Stem Cell Trial, Primary Ovarian Insufficiency

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Summary

NIH registered a Phase 1 clinical trial (NCT07551895) evaluating umbilical cord mesenchymal stem cell (UC-MSC) injection (HS_SW01 cells) in patients with Primary Ovarian Insufficiency (POI). The trial aims to assess safety, tolerability, and efficacy of the investigational stem cell therapy. Participants will be enrolled after signing informed consent and meeting protocol inclusion/exclusion criteria.

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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

NIH registered a new Phase 1 clinical trial (NCT07551895) investigating human umbilical cord mesenchymal stem cell injection (HS_SW01 cells) for the treatment of Primary Ovarian Insufficiency (POI). The trial will evaluate safety, tolerability and efficacy endpoints in enrolled participants who meet inclusion/exclusion criteria and sign informed consent.

Healthcare providers and clinical investigators should note this represents early-stage cellular therapy research in reproductive endocrinology. Sponsors of similar stem cell programs for women's health indications may reference this trial's design for regulatory pathway considerations.

Archived snapshot

Apr 28, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

Phase 1 NCT07551895 Kind: PHASE1 Apr 27, 2026

Abstract

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).

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.

Conditions: Primary Ovarian Insufficiency (Poi)

Interventions: HSSW01 cells injection, HSSW01 cells injection, HS_SW01 cells injection

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators Healthcare providers Patients
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Stem cell therapy research Clinical trial participation
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Pharmaceuticals Medical Devices

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