Effects of UCA-PSCs in Women With POF

Premature Ovarian Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05138367
• Other study ID #: SZ-POF-2018-12
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: November 2021
• Source: Nanjing University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Procedure:
• transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients
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.

Locations

Country	Name	City	State
China	Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Li-jun Ding

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood perfusion in the ovary	Systolic/Diastolic blood pressure (S/D) value was monitored in bilateral ovaries by transvaginal color Doppler ultrasound detector.	within the first 30 weeks (plus or minus 10 weeks) after surgery
Primary	Antral Follicle Diameter	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.	within the first 30 weeks (plus or minus 10 weeks) after surgery
Secondary	blood flow index in the ovaries	The blood flow spectrum in bilateral ovaries was monitored by transvaginal color Doppler ultrasound detector, including pulsatility index (PI), resistance index (RI).	within the first 30 weeks (plus or minus 10 weeks) after surgery