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Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF

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ClinicalTrials.gov Identifier: NCT02644447
Recruitment Status : Unknown
Verified December 2015 by Jianwu Dai, Chinese Academy of Sciences.
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2015
Last Update Posted : July 27, 2017
Sponsor:
Collaborator:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

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.

Condition or disease Intervention/treatment Phase
Premature Ovarian Failure Biological: HUC-MSCs Transplantation Biological: HUC-MSCs with Injectable Collagen Scaffold Transplantation Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Study Start Date : October 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: HUC-MSCs Transplantation Biological: HUC-MSCs Transplantation
The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.

Experimental: HUC-MSCs with Injectable Collagen Scaffold Transplantation Biological: HUC-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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644447


Locations
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China, Jiangsu
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
Chinese Academy of Sciences
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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Principal Investigator: Jianwu Dai, Ph.D Chinese Academy of Sciences

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Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02644447     History of Changes
Other Study ID Numbers: CAS-XDA-POF/IGDB
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: December 2015

Additional relevant MeSH terms:
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Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases