Premature Ovarian FailurePhase 1NCT05138367
Effects of UCA-PSCs in Women With POF
A Phase 1 study testing transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients in people with Premature Ovarian Failure, run by Li-jun Ding at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 1 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: 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.
Read the 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)
- Conditions
- Premature Ovarian Failure
- Being tested
- transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients
- Keywords
- POF
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patientsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood perfusion in the ovary
Systolic/Diastolic blood pressure (S/D) value was monitored in bilateral ovaries by transvaginal color Doppler ultrasound detector.
Measured: 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.
Measured: within the first 30 weeks (plus or minus 10 weeks) after surgery
Secondary outcomes (1)
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).
Measured: within the first 30 weeks (plus or minus 10 weeks) after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Dec 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Li-jun Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li-jun Ding, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138367
- Sponsor's protocol ID
- SZ-POF-2018-12
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Human Umbilical Artery Derived Perivascular Stem Cells in the Treatment of Premature Ovarian Failure
- ClinicalTrials.gov ID
- NCT05138367
- Acronym / sponsor ID
- SZ-POF-2018-12
- Conditions
- Premature Ovarian Failure
- Keywords
- POF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Li-jun DingUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCA-PSC | Experimental | Procedure: transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patientsSubsequent 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 | Experimental | Procedure: transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patientsSubsequent 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). |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Patients with chromosome abnormalities
- Patients with congenital ovarian malformations
- Patients with severe endometriosis
- Patients with thyroid dysfunction
- Patients with pregnancy contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patientsAfter 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. | Procedure or surgery | UCA-PSC, WJ-MSC |
Primary outcome
blood perfusion in the ovary
Time frame: 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.
Antral Follicle Diameter
Time frame: 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.
1 secondary outcome
blood flow index in the ovaries
Time frame: within the first 30 weeks (plus or minus 10 weeks) after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing transplantation of human UCA-PSCs or WJ-MSCs into ovaries of POF patients in people with Premature Ovarian Failure, run by Li-jun Ding at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood perfusion in the ovary (time frame: within the first 30 weeks (plus or minus 10 weeks) after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.