Effects of UCA-PSCs in Women With POF

Li-jun Ding

Status and phase: Completed; Phase 1

Conditions: Premature Ovarian Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05138367

SZ-POF-2018-12

Details and patient eligibility

About

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.

Full 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)

Enrollment: 20 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

UCA-PSC

Experimental group

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).

Treatment:

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

WJ-MSC

Experimental group

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).

Treatment:

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