Reprogramming of Activated Pancreatic Stellate Cells via Mechanical Modulation of Transmembrane Force-sensitive N-cadherin Receptor.
Huan Zhang, Hongyuan Zhu, Jinteng Feng...
https://pubmed.ncbi.nlm.nih.gov/36089055Actively Recruiting
Phase 1
Phase 2
Age: 20Years - 40Years
FEMALE
ID06896747
Evaluation of Therapeutic Effects of Mechanically Engineered Umbilical Cord-Derived Stem Cell Exosomes on Endometrial Injury: A Prospective, Non-Randomized, Parallel-Controlled Clinical Study
Led by Tang-Du Hospital · Updated on 2025-03-26
90
Participants Needed
2
Research Sites
93 weeks
Total Duration
On this page
Sponsors
T
Tang-Du Hospital
Lead Sponsor
X
Xi'an Jiaotong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether engineered mechanically umbilical cord-derived stem cell exosomes or conventional umbilical cord-derived stem cell exosomes can improve the thickness of the endometrium in women with thin endometrium caused by severe intrauterine adhesions after hysteroscopic adhesiolysis. The study aims to compare the effectiveness of these exosomes versus platelet-rich plasma (PRP), a commonly used treatment, in improving endometrial thickness and pregnancy outcomes. This clinical trial is prospective, non-randomized, and parallel-controlled, focusing on regenerative therapies for reproductive medicine challenges like recurrent implantation failure and pregnancy complications. Participants are divided into three groups receiving different treatments via hysteroscopically guided intra-endometrial injection during the proliferative phase (Day 3-7 of the menstrual cycle). One group receives mechanically engineered umbilical cord mesenchymal stem cell-derived exosomes (ME-UCMSC-Exo), another receives conventional umbilical cord mesenchymal stem cell-derived exosomes (UCMSC-Exo), and the control group receives autologous PRP. Each injection delivers 1 to 1.5 mL of the respective treatment. The study evaluates whether mechanical preconditioning of exosomes enhances their regenerative effects compared to conventional exosomes and PRP. Participants will be monitored before treatment and at multiple follow-up points including during embryo transfer cycles and pregnancy assessments up to one year post-intervention. Researchers will measure changes in endometrial thickness, clinical pregnancy rates, implantation rates, live births, and miscarriage rates while monitoring safety through adverse reaction tracking and evaluations of organ function and tumor markers. Total participation includes treatment and follow-up visits over a period extending to one year after intervention.
CONDITIONS
Brief Title
Evaluating Mechanically Engineered Stem Cell Exosomes for Treating Endometrial Injury: A Clinical Study
Who Can Participate
Age: 20Years - 40Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Females aged 20 to 40 years inclusive
- Normal ovarian reserve function (AFC ≥ 7, AMH > 1.1 ng/mL)
- History of transcervical resection of adhesions (TCRA)
- Received platelet-rich plasma (PRP) treatment after TCRA
- At least one embryo transfer cycle with standard ovarian stimulation or hormone therapy and endometrial thickness less than 7 mm
- Planned to continue IVF, ICSI, or frozen embryo transfer-assisted conception
- Able to accept and follow treatment and follow-up, and willing to sign informed consent
You will not qualify if you...
- Severe systemic diseases, surgical contraindications, or contraindications to menstrual cycles
- Reproductive tract infections, genital tuberculosis, pelvic inflammatory disease, or malignant tumors of reproductive organs
- Systemic diseases causing uterine bleeding
- Allergies to any drugs, materials, or components used in the study
- High risk for hormone-dependent tumors such as breast or ovarian tumors
- Untreated submucosal fibroids of any size (FIGO 0/I/II), uterine fibroids ≥5 cm (FIGO III-VII), adenomyosis, unicornuate or bicornuate uterus, or endometrial polyps
- Hydrosalpinx ≥3 cm or hydrosalpinx with significant vaginal discharge
- Ovarian endometriotic cysts (chocolate cysts) ≥4 cm
- Participation in other clinical trials within 3 months prior to surgery or during the study
- Unable to tolerate anesthesia
- Genetic abnormalities
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment during one menstrual cycle
Participants receive a single intra-endometrial injection of either mechanically engineered umbilical cord mesenchymal stem cell-derived exosomes, conventional umbilical cord mesenchymal stem cell-derived exosomes, or autologous platelet-rich plasma during the proliferative phase (Day 3-7) of their menstrual cycle using hysteroscopic guidance.
1 treatment visit (in-person)
Follow-up
Duration - Up to 1 year post-treatment
Participants are monitored for treatment efficacy and safety including assessments of endometrial thickness, pregnancy outcomes, and adverse reactions such as allergic responses and infections. Follow-up includes short-term evaluations around embryo transfer and longer-term safety assessments up to one year post-intervention.
Multiple visits including baseline, day of progesterone transformation, 7 days post-progesterone, embryo transfer cycle visits, and periodic safety follow-ups
Trial Site Locations
Total: 2 locations
1
Tang-Du Hospital
Xi'an, Shaanxi, China, 710038
Actively Recruiting
2
Tang-Du Hospital
Xi'an, Shaanxi, China, 710038
Actively Recruiting
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Research Team
W
Wanlin Zhang, PhD
Y
Yafei Tong, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/39643206