Back to resultsEffects of UCA-PSCs in Women With POF
Primary Purpose
Premature Ovarian Failure
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ovarian Failure focused on measuring POF
Eligibility Criteria
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
Sites / Locations
- Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
UCA-PSC
WJ-MSC
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
blood perfusion in the ovary
Systolic/Diastolic blood pressure (S/D) value was monitored in bilateral ovaries by transvaginal color Doppler ultrasound detector.
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05138367
Brief Title
Effects of UCA-PSCs in Women With POF
Official Title
Clinical Study of Human Umbilical Artery Derived Perivascular Stem Cells in the Treatment of Premature Ovarian Failure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li-jun Ding
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Failure
Keywords
POF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UCA-PSC
Arm Type
Experimental
Arm Description
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).
Arm Title
WJ-MSC
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients
Intervention Description
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 Outcome Measure Information:
Title
blood perfusion in the ovary
Description
Systolic/Diastolic blood pressure (S/D) value was monitored in bilateral ovaries by transvaginal color Doppler ultrasound detector.
Time Frame
within the first 30 weeks (plus or minus 10 weeks) after surgery
Title
Antral Follicle Diameter
Description
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.
Time Frame
within the first 30 weeks (plus or minus 10 weeks) after surgery
Secondary Outcome Measure Information:
Title
blood flow index in the ovaries
Description
The blood flow spectrum in bilateral ovaries was monitored by transvaginal color Doppler ultrasound detector, including pulsatility index (PI), resistance index (RI).
Time Frame
within the first 30 weeks (plus or minus 10 weeks) after surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study of POF is only for people whose physical sex is female.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of UCA-PSCs in Women With POF
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