Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical Study
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorTang-Du Hospital
About this trial
The goal of this clinical trial is to evaluate if engineered mechanically umbilical cord-derived stem cell exosomes, or conventional umbilical cord -derived stem cell exosomes, can improve endometrial thickness in women with thin endometrium.
The main questions it aims to answer are:
Can exosomes delivered via subendometrial injection improve endometrial thickness or clinical pregnancy rates compared to PRP (platelet-rich plasma)? Are there significant differences in endometrial thickness between the two treatment groups? Researchers will compare the intervention groups, which one group receives mechanical exosomes and the other receives conventional esosomes via subendometrial injection, to the control group, which receives PRP via the same methods, to see if exosomes provide superior therapeutic effects.
Participants will:
Receive either mechanical exosomesor or conventional esosomes or PRP through subendometrial injection.
Be monitored for changes in endometrial parameters.
Eligibility criteria
Qualifiers
Females aged 20-40 years (inclusive of boundary values);
Normal ovarian reserve function (criteria: AFC ≥ 7, AMH > 1.1 ng/mL);
History of transcervical resection of adhesions (TCRA);
Received PRP treatment after TCRA;
Disqualifiers
Patients with severe systemic diseases, surgical contraindications, or cycle contraindications;
Patients with reproductive tract infections, genital tuberculosis, pelvic inflammatory disease, or malignant tumors of reproductive organs;
Patients with systemic diseases that cause uterine bleeding;
Patients allergic to any drugs, materials, or components used in this study;
Trial design
Treatments tested in this trial
- Mechanically Engineered Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes
- Umbilical cord mesenchymal stem cell-derived exosomes
- platelet-rich plasma
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Tang-Du Hospital
Lead sponsor
Xi'an Jiaotong University
Collaborator
Source ClinicalTrials.gov