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

NCT03877471 | Unknown Phase 1 DMC

• 1 other identifier: IOZ ChineseAS POI-2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Ovarian Insufficiency

Keywords

Mesenchymal stem cell; Transplantation; Human embryonic stem cell; Premature ovarian failure

Outcome Measures

Primary Outcomes (4)

• Temperature

  Body temperature of the participants will be measured fortnightly after injection.

  0-24 weeks

• Pulse

  Pulse of the participants will be measured fortnightly after injection.

  0-24 weeks

• Breaths per minute

  Breathing rate of the participants will be measured fortnightly after injection.

  0-24 weeks

• Blood pressure

  Both systolic pressure and diastolic pressure of the participants will be assessed fortnightly after injection.

  0-24 weeks

Secondary Outcomes (5)

• Number of antral follicle

  0-24 weeks

• Follicle-stimulating hormone (FSH) serum level

  0-24 weeks

• Estradiol (E2) serum level

  0-24 weeks

• Anti-Mullerian hormone (AMH) serum level

  0-24 weeks

• Ovarian volume

  0-24 weeks

Study Arms (3)

Low dosage

EXPERIMENTAL

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

Genetic: Cell therapy

Medium dosage

EXPERIMENTAL

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

Genetic: Cell therapy

High dosage

EXPERIMENTAL

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

Genetic: Cell therapy

Interventions

Cell therapy GENETIC

Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary.

High dosage; Low dosage; Medium dosage

Eligibility Criteria

• Age: Up to 40 Years
• Gender Eligibility Details: Only female will be enrolled.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Hongmei Wang, Doctor

  Institute of Zoology, Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 15, 2019
• Study Start: April 3, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 31, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)