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NCT Number: NCT05138367

Effects of UCA-PSCs in Women With POF

This study was a single-center randomized controlled trial at the Affiliated Drum Tower Hospital of Nanjing University Medical School. There were patients who underwent clinical follow-ups since 2018 in POF clinic. Patients were given treatment of either UCA-PSC or WJ-MSC.

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Key information

Conditions

Premature Ovarian Failure Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

About this study

At entry, all patients had already received a standard non-physiologic hormone replacement regimen. According to blinded preferences for participation, patients were randomized into two treatment groups after an initial 2-month washout period of no therapy. One group received UCA-PSC transplantation plus horone replacement treatment (HRT) (UCA-PSC group), while the other group received WJ-MSC transplantation plus HRT (collagen/WJ-MSC group)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Premature Ovarian Failure
  • Patients show no response to drug treatment
  • Willing to receive follow up
  • Willing to conceive a baby
  • Age between 18 to 39

Exclusion criteria

  • Patients with chromosome abnormalities
  • Patients with congenital ovarian malformations
  • Patients with severe endometriosis
  • Patients with thyroid dysfunction
  • Patients with pregnancy contraindications
  • Patients with hormone replacement therapy contraindications
  • Past history of ovarian tumors or after radiotherapy
  • Can not take the follow-up, or want to take other treatment during the follow-up period
  • Patients with immune system diseases

Treatment and study plan

transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients

Procedure

After vaginal sterilization, TVUS-guided transplantation was performed by the senior-level medical physician B Wang), using a SIEMENS ACUSON ANTANES premium edition system (SIEMENS AG Healthcae Sector, Erlangen, Germany), equipped with a 6-10 MHz probe. The solution (a total number of 2×10^7cells, 1×10^7 /400 μL for unilateral ovarian injection) was injected into the ovary by using 21G PTC needles (Hakko Medical Co, Japan) under TVUS guiance. Each patent received up to three transplantations.

Primary outcomes

  1. blood perfusion in the ovary

    Time frame: within the first 30 weeks (plus or minus 10 weeks) after surgery

    Systolic/Diastolic blood pressure (S/D) value was monitored in bilateral ovaries by transvaginal color Doppler ultrasound detector.

  2. Antral Follicle Diameter

    Time frame: within the first 30 weeks (plus or minus 10 weeks) after surgery

    An antral follicle (or Graafian follicle) is an ovarian follicle during a certain latter stage of folliculogenesis. The antral follicle diameter in the ovaries were record using transvaginal ultrasound scan.

Secondary outcomes

  1. blood flow index in the ovaries

    Time frame: within the first 30 weeks (plus or minus 10 weeks) after surgery

    The blood flow spectrum in bilateral ovaries was monitored by transvaginal color Doppler ultrasound detector, including pulsatility index (PI), resistance index (RI).

Sponsors and collaborators

Lead sponsor

Li-jun Ding

Other

Registry information

Official study title

Clinical Study of Human Umbilical Artery Derived Perivascular Stem Cells in the Treatment of Premature Ovarian Failure

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 1, 2021
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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