Effects of UCA-PSCs in Women With POF

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

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.

Study Overview

• Status: Completed
• Conditions: Premature Ovarian Failure
• Intervention / Treatment: Procedure: transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UCA-PSC; 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; 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.
Experimental: WJ-MSC; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Li-jun Ding

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 17, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: POF
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: SZ-POF-2018-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No