Transplantation of hAMSCs for Woman With DOR | NCT04706312

Studies
Transplantation of hAMSCs for Woman With DOR

NCT04706312

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Unknown status

Last Update Posted

Feb 9, 2021Actual

Enrollment

12Estimated

Phase

Phase 1

Conditions

Diminished Ovarian Response

Interventions

stem cells

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2021Estimated

Primary Completion Date

Jan 2022Estimated

Completion Date

Apr 2024Estimated

First Submitted Date

Jan 10, 2021

First Submission Date that Met QC Criteria

Jan 10, 2021

First Posted Date

Jan 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2021

Last Update Posted Date

Feb 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

Patients with Diminished ovarian response (DOR）have a poor in vitro fertilization（IVF） outcome, and is considered one of most challenging tasks in artificial reproductive treatment (ART). Stem cell therapies are rapidly progressing fields and have shown immense promise in the treatment of lots of disease, including aging and premature ovarian failure. The purpose of this study is to determine the safety and efficacy of intra vein injection of human amniotic mesenchymal stem cells(hAMSCs) in women suffered from infertility caused by DOR. The hAMSCs were isolated and cultured in vitro and qualified by National Institutes for Food and Drug Control, China. The serum of each patient was kept and sent for laboratory test before the transplantation. The biomarkers of hAMSCs were detected again before transplantation. The hAMSCs were transplanted via venous in the dorsum of hand. The outcomes of patients were examined during and after the injection. The patients are monitored for hormones, follicles stimulated with minimal stimulation, number of oocyte retrieval and embryos In Vitro Fertilization (IVF).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hAMSCs injection	Experimental	hAMSCs were injected via venous in the dorsum of hand.	Other: stem cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stem cells	Other	hAMSCs injection via venous in the dorsum of hand	hAMSCs injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability after hAMSCs injection.	Safety and tolerability assessed by Adverse Events and serious during injection and adverse events (SAEs) after injection assessed by long term follow-up .	Up to 12 months after first hAMSCs injection
The ratio of transplantable embryo in DOR patients after hAMSCs injection.	The ratio of transplantable embryo to normal fertilized embryos in DOR patients after hAMSCs injection.	Up to 12 months after first hAMSCs injection

Secondary Outcomes

Measure	Description	Time Frame
Ovarian function in DOR patients after hAMSCs injection.	Anti-müllerian Hormone (AMH) serum level, Follicle Stimulating Hormone (FSH) serum level, Estradiol (E2) serum level, Luteinizing Hormone (LH)serum level on menstrual day 2/3 will be evaluated after injection. The number of antral follicles will be recorded by transvaginal ultrasound scan.	Up to 12 months after first hAMSCs injection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women between35 and 45 years, who is diagnosed with Diminished Ovarian Reserve by Bologna criteria, (AFC≤7，or serum AMH level < 1.10ng/ml), and failed pregnancies in at least two cycles of In Vitro Fertilization(IVF) or Intracytoplasmic Sperm Injection(ICSI).
Willing to sign the Informed Consent Form.

Exclusion Criteria:

Patients diagnosed with hereditary, immunological and iatrogenic premature ovarian failure
Patients allergy to blood products
Patients diagnosed with abnormal coagulation function
Patients diagnosed with uterine malformation
Patients undergoing Preimplantation Genetic Testing
Patients diagnosed with hydrosalpinx
Patients diagnosed with infectious diseases
Contraindications for In Vitro Fertilization-Embryo Transfer(IVF-ET) or pregnancy
Prior personal history of stem cell clinical trail or other clinical trails
Unwilling to comply with study protocol
Patients identified with high risk for stem cell injection

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiang Ma, Doctor	Contact	+8618001581878		sxmaxiang@126.com
Lianju Qin, Doctor	Contact	+86 18012923584		ljqin@njmu.edu.cn

Overall Officials

Name	Affiliation	Role
Jiayin Liu, Doctor	First Affiliated Hospital, Nanjing Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University		Nanjing	Jiangsu	210000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided