Effects of UCA-PSCs in Women With POF

Phase 1

Completed

• Conditions: Premature Ovarian Failure
• Interventions: Procedure: transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients

• Registration Number: NCT05138367
• Lead Sponsor: Li-jun Ding

Brief Summary

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.

Detailed Description

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)

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Study First Submitted: 2021-10-28
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-17
• Last Update Submitted: 2021-11-17
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. Clinical diagnosis of Premature Ovarian Failure
2. Patients show no response to drug treatment
3. Willing to receive follow up
4. Willing to conceive a baby
5. Age between 18 to 39

Exclusion Criteria

1. Patients with chromosome abnormalities
2. Patients with congenital ovarian malformations
3. Patients with severe endometriosis
4. Patients with thyroid dysfunction
5. Patients with pregnancy contraindications
6. Patients with hormone replacement therapy contraindications
7. Past history of ovarian tumors or after radiotherapy
8. Can not take the follow-up, or want to take other treatment during the follow-up period
9. Patients with immune system diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UCA-PSC	transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients	Subsequent to isolation and culture of UCA-PSCs, UCA-PSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the National Institute for China Food and Drug Control) were injected into the ovaries of patients with hormone replacement treatment, which consisted of Premarin (0.625 mg/days on days 1 through 25) combined with Provera (10 mg/day for 10 days a month with monthly withdrawal bleeding).
WJ-MSC	transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients	Subsequent to isolation and culture of WJ-MSCs, WJ-MSCs (GMP grade, from Clinical Center for Stem Cell Research of the Affiliated Drum Tower Hospital of Nanjing University Medical School, licensed by the National Institute for China Food and Drug Control) were injected into the ovaries of patients with hormone replacement treatment, which consisted of Premarin (0.625 mg/days on days 1 through 25) combined with Provera (10 mg/day for 10 days a month with monthly withdrawal bleeding).

Primary Outcome Measures

Name	Time	Method
Antral Follicle Diameter	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.
blood perfusion in the ovary	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.

Secondary Outcome Measures

Name	Time	Method
blood flow index in the ovaries	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).

Trial Locations

Locations (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China