Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)

Royan Institute

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Premature Ovarian Failure

Treatments: Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)

Study type: Interventional

Funder types: Other

Identifiers

NCT02603744

Rep-Bio-Royan-001

Details and patient eligibility

About

The goal of this study is to determine safety and tolerability and of intra-ovarian injection of adipose derived stromal cell in women with premature ovarian failure and to study the preliminary efficacy ADSCs intra ovarian injection on ovarian function improvement.

Full description

In this study 9 patients with the diagnosis of premature ovarian failure will participate.

The patients will be divided randomly in 3 groups, each group contains 3 patients. First group will receive 5 millions of ADSCs, second group receive 10 millions cells and the third group receive 15millions of ADSCs.

Stem cell Transplantation method is intraovarian injection of ADSCs which will be performed under guidance of transvaginal sonography.

All the patients will be followed for 12 months after cell injection to evaluate any adverse events .

Enrollment: 9 estimated patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female
• Age : 20-39
• FSH>20

Exclusion criteria

• liposuction contraindication
• thyroid dysfunction
• immune system disease
• past history of cancer , chemotherapy , radiotherapy
• HIV+, hepatitis B, C
• Severe endometriosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

5 million MSC

Experimental group

Description:

The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells.

Treatment:

Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)

10 million MSC

Experimental group

Description:

The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells.

Treatment:

Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)

15 million MSC

Experimental group

Description:

The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells.

Treatment:

Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)