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NCT Number: NCT02644447

Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF

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.

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Key information

Conditions

Premature Ovarian Failure Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Premature Ovarian Failure.
  • Patients show no response to drug treatment
  • Women between 20 and 39 years.
  • Willing to sign the Informed Consent Form.

Exclusion criteria

  • Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome).
  • Congenital ovarian malformation.
  • Severe endometriosis.
  • Thyroid dysfunction.
  • Contraindications for pregnancy.
  • Contraindications for hormone replacement therapy.
  • Prior personal history of ovarian cancer or after radiotherapy.
  • Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period.

Treatment and study plan

HUC-MSCs Transplantation

Biological

The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.

HUC-MSCs with Injectable Collagen Scaffold Transplantation

Biological

The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.

Primary outcomes

  1. Safety and Tolerability assessed by Adverse Events

    Time frame: Up to 6 months

    Proportion of patients with postoperative infections and serious adverse events (SAEs) were assessed by long term follow-up.

Secondary outcomes

  1. Number of Antral follicle development

    Time frame: Once a week within 3 months after the surgery

    The number of follicles developing was recorded by transvaginal ultrasound scan.

  2. Estradiol (E2) serum level

    Time frame: Once a week within 3 months after the surgery

    Serum E2 level was evaluated after surgery.

  3. Follicle Stimulating Hormone (FSH) serum level

    Time frame: Once a week within 3 months after the surgery

    Serum FSH level was evaluated after surgery.

  4. Anti-Mullerian Hormone (AMH) serum level

    Time frame: Once a week within 3 months after the surgery

    Serum AMH level was evelated after surgery.

  5. Pregnancy rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Registry information

Official study title

The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) With Injectable Collagen Scaffold Transplantation in Woman With Premature Ovarian Failure (POF)

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 31, 2015
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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