Effects of UCA-PSCs in Women With POF

NCT05138367 | Completed Phase 1

• 1 other identifier: SZ-POF-2018-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ovarian Failure

Keywords

POF

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• blood flow index in the ovaries

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

Study Arms (2)

UCA-PSC

EXPERIMENTAL

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).

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

WJ-MSC

EXPERIMENTAL

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).

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

Interventions

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.

UCA-PSC; WJ-MSC

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: Study of POF is only for people whose physical sex is female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Li-jun Ding: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 1, 2021
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

CN (1)