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Mesenchymal Stem Cells (MSCs) - Like Cell Transplantation in Women With Primary Ovarian Insufficiency (MSCLCTWPOI)

Primary Purpose

Primary Ovarian Insufficiency

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Cell therapy
Sponsored by
Chinese Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Ovarian Insufficiency focused on measuring Mesenchymal stem cell, Transplantation, Human embryonic stem cell, Premature ovarian failure

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Under 40 years of age;
  2. Have established regular menstrual cycle, oligomenorrhea / amenorrhea ≥ 4 months;
  3. FSH (Follicle-Stimulating Hormone) > 25 IU/mL;
  4. Bilateral ovaries are visible by ultrasound;
  5. Have fertility requirement, husband has sperms;
  6. Willing to sign the Informed Consent Form.

Exclusion Criteria:

  1. Primary amenorrhea;
  2. History of serious drug allergy or allergic constitution;
  3. Thrombophlebitis and thromboembolia, past and present;
  4. Acute or chronic infection, hematologic disease, angiocardiopathy, pulmonary disease, liver disease, nephropathy, pancreas disease
  5. Autoimmune disease, history of severe familial genetic disease, etc.
  6. Anatomical abnormality of reproductive system;
  7. Contraindications for pregnancy;
  8. Spouse azoospermia;
  9. HIV+, hepatitis B, C;
  10. Thyroid dysfunction;
  11. History of previous malignant or ovarian tumors, history of ovarian therapy;
  12. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);
  13. During pregnancy or lactation;
  14. Alcohol or other substance abuse;
  15. Mental disease, communicate obstruction;
  16. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period;
  17. Attending doctor consider inappropriate to take part in.

Sites / Locations

  • The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low dosage

Medium dosage

High dosage

Arm Description

The low dosage will inject 2 million MSC-like cells (in 100ul suspension) for each ovary.

The medium dosage will inject 5 million MSC-like cells (in 100ul suspension) for each ovary.

The high dosage will inject 10 million MSC-like cells (in 100ul suspension) for each ovary.

Outcomes

Primary Outcome Measures

Temperature
Body temperature of the participants will be measured fortnightly after injection.
Pulse
Pulse of the participants will be measured fortnightly after injection.
Breaths per minute
Breathing rate of the participants will be measured fortnightly after injection.
Blood pressure
Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.

Secondary Outcome Measures

Number of antral follicle
The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection.
Follicle-stimulating hormone (FSH) serum level
Serum FSH level will be tested fortnightly after injection.
Estradiol (E2) serum level
Serum E2 level will be tested fortnightly after injection.
Anti-Mullerian hormone (AMH) serum level
Serum AMH level will be tested fortnightly after injection.
Ovarian volume
The ovarian volume will be recorded fortnightly by transvaginal ultrasound after injection.

Full Information

First Posted
March 11, 2019
Last Updated
August 4, 2021
Sponsor
Chinese Academy of Sciences
Collaborators
The First Affiliated Hospital of Zhengzhou University, National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT03877471
Brief Title
Mesenchymal Stem Cells (MSCs) - Like Cell Transplantation in Women With Primary Ovarian Insufficiency
Acronym
MSCLCTWPOI
Official Title
Safety Study of Human Embryonic Stem Cell Derived Mesenchymal Stem Cell (MSC)-Like Cells Transplantation in Women With Primary Ovarian Insufficiency (POI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
The First Affiliated Hospital of Zhengzhou University, National Natural Science Foundation of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). So far, there was no treatment sufficient enough to cure POI. Cell therapy is a rapidly developing field and have shown immense promise in the treatment of ovarian dysfunction. In this study, the investigator will evaluate the safety of MSC-like cell therapy in women suffering from POI.
Detailed Description
The purpose of this work is to explore the safety and preliminary efficacy of human embryonic stem cell derived MSC-like cell transplantation in women with POI. MSC-like cells were injected directly into bilateral ovaries under transvaginal ultrasound. Patients are subjected into 3 groups, with low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells injection for each ovary. The outcomes of patients were followed after the injection every 2 weeks. The investigator mainly follow the safety indexes, and the level of sex hormone and signs of follicle growth will also be monitored. The growing follicles will be stimulated by exogenous hormone, followed by oocyte retrieval and in vitro fertilization (IVF).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ovarian Insufficiency
Keywords
Mesenchymal stem cell, Transplantation, Human embryonic stem cell, Premature ovarian failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Patients will be subjected into 3 groups, with a low (0.2×107), medium (0.5×107) and high dosage (1.0×107) of cells transplantation for each ovary. The investigator will first carry out the low dosage group, and then the medium dosage group, based on the safety evaluation of the previous group, the high dosage group will be executed in the same way.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dosage
Arm Type
Experimental
Arm Description
The low dosage will inject 2 million MSC-like cells (in 100ul suspension) for each ovary.
Arm Title
Medium dosage
Arm Type
Experimental
Arm Description
The medium dosage will inject 5 million MSC-like cells (in 100ul suspension) for each ovary.
Arm Title
High dosage
Arm Type
Experimental
Arm Description
The high dosage will inject 10 million MSC-like cells (in 100ul suspension) for each ovary.
Intervention Type
Genetic
Intervention Name(s)
Cell therapy
Intervention Description
Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary.
Primary Outcome Measure Information:
Title
Temperature
Description
Body temperature of the participants will be measured fortnightly after injection.
Time Frame
0-24 weeks
Title
Pulse
Description
Pulse of the participants will be measured fortnightly after injection.
Time Frame
0-24 weeks
Title
Breaths per minute
Description
Breathing rate of the participants will be measured fortnightly after injection.
Time Frame
0-24 weeks
Title
Blood pressure
Description
Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.
Time Frame
0-24 weeks
Secondary Outcome Measure Information:
Title
Number of antral follicle
Description
The number of antral follicles developing will be recorded by transvaginal ultrasound fortnightly after injection.
Time Frame
0-24 weeks
Title
Follicle-stimulating hormone (FSH) serum level
Description
Serum FSH level will be tested fortnightly after injection.
Time Frame
0-24 weeks
Title
Estradiol (E2) serum level
Description
Serum E2 level will be tested fortnightly after injection.
Time Frame
0-24 weeks
Title
Anti-Mullerian hormone (AMH) serum level
Description
Serum AMH level will be tested fortnightly after injection.
Time Frame
0-24 weeks
Title
Ovarian volume
Description
The ovarian volume will be recorded fortnightly by transvaginal ultrasound after injection.
Time Frame
0-24 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female will be enrolled.
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Under 40 years of age; Have established regular menstrual cycle, oligomenorrhea / amenorrhea ≥ 4 months; FSH (Follicle-Stimulating Hormone) > 25 IU/mL; Bilateral ovaries are visible by ultrasound; Have fertility requirement, husband has sperms; Willing to sign the Informed Consent Form. Exclusion Criteria: Primary amenorrhea; History of serious drug allergy or allergic constitution; Thrombophlebitis and thromboembolia, past and present; Acute or chronic infection, hematologic disease, angiocardiopathy, pulmonary disease, liver disease, nephropathy, pancreas disease Autoimmune disease, history of severe familial genetic disease, etc. Anatomical abnormality of reproductive system; Contraindications for pregnancy; Spouse azoospermia; HIV+, hepatitis B, C; Thyroid dysfunction; History of previous malignant or ovarian tumors, history of ovarian therapy; Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome); During pregnancy or lactation; Alcohol or other substance abuse; Mental disease, communicate obstruction; Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period; Attending doctor consider inappropriate to take part in.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongmei Wang, Doctor
Organizational Affiliation
Institute of zoology, Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigator have not recruited enough participant yet, till now, most of them would like to keep the individual participant data classified.

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Mesenchymal Stem Cells (MSCs) - Like Cell Transplantation in Women With Primary Ovarian Insufficiency

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