Premature Ovarian Failure
Conditions
Brief summary
Cellular therapies are rapidly progressing fields and have shown immense promise in the treatment of damaged ovarian function. The purpose of this study is to determine safety and efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.
Detailed description
The purpose of this study was to explore the therapeutic potency of the HUC-MSCs with injectable collagen scaffold transvaginal injection for POF women. The serum of each patient was kept and sent for laboratory test before the surgery. HUC-MSCs were isolated and cultured in vitro and the biomarkers of HUC-MSCs were detected using Flow cytometry detection. The HUC-MSCs with injectable collagen scaffold were then injected directly into bilateral ovaries. The outcomes of patients were examined after the injection. The patients are monitored for signs of follicle growth and growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and In Vitro Fertilization (IVF).
Interventions
BIOLOGICALHUC-MSCs Transplantation
The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.
BIOLOGICALHUC-MSCs with Injectable Collagen Scaffold Transplantation
The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with Premature Ovarian Failure. 2. Patients show no response to drug treatment 3. Women between 20 and 39 years. 4. Willing to sign the Informed Consent Form.
Exclusion criteria
1. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome). 2. Congenital ovarian malformation. 3. Severe endometriosis. 4. Thyroid dysfunction. 5. Contraindications for pregnancy. 6. Contraindications for hormone replacement therapy. 7. Prior personal history of ovarian cancer or after radiotherapy. 8. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability assessed by Adverse Events | Up to 6 months | Proportion of patients with postoperative infections and serious adverse events (SAEs) were assessed by long term follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Antral follicle development | Once a week within 3 months after the surgery | The number of follicles developing was recorded by transvaginal ultrasound scan. |
| Estradiol (E2) serum level | Once a week within 3 months after the surgery | Serum E2 level was evaluated after surgery. |
| Follicle Stimulating Hormone (FSH) serum level | Once a week within 3 months after the surgery | Serum FSH level was evaluated after surgery. |
| Anti-Mullerian Hormone (AMH) serum level | Once a week within 3 months after the surgery | Serum AMH level was evelated after surgery. |
| Pregnancy rate | 2 weeks after embryo implantation | The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection. |
Countries
China
Outcome results
None listed