Premature Ovarian FailurePhase 1/2NCT02603744
Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)
A Phase 1/2 study testing Intraovarian injection of Adipose derived Stromal cells (ADSCs) in people with Premature Ovarian Failure, run by Royan Institute at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- Intraovarian injection of Adipose derived Stromal cells (ADSCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteIran
- Study dates
- Jun 2015to Nov 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female
- Age : 20-39
- FSH>20
Who cannot join
- liposuction contraindication
- thyroid dysfunction
- immune system disease
- past history of cancer , chemotherapy , radiotherapy
- HIV+, hepatitis B, C
- Severe endometriosis
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Royan Institute
Tehran
Nasser Aghdami, MD,PhD, (+98)23562000 ext. 516, nasser.aghdami@royaninstitute.org
Leila Arab, MD, (+98)23562000 ext. 414, Leara91@gmail.com
About this study
Official title: Evaluate the Safety and Feasibility of Intra-ovarian Injection of Autologous Adipose Derived Mesenchymal Stromal Cells (ADMSC) in Women With Premature Ovarian Failure(POF)
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.
Read the detailed 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 .
- Conditions
- Premature Ovarian Failure
- Being tested
- Intraovarian injection of Adipose derived Stromal cells (ADSCs)
- Keywords
- Premature ovarian failure adipose derived stromal cells intraovarian injection
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraovarian injection of Adipose derived Stromal cells (ADSCs)Biological
Also called stem cell transplantation
Intra-ovarian injection of Adipose derived mesenchymal stem cells.
| Study group | Role | What they receive |
|---|---|---|
| 5 million MSC | Experimental | The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells. Receives: Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs) |
| 10 million MSC | Experimental | The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells. Receives: Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs) |
| 15 million MSC | Experimental | The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells. Receives: Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovary mass
Evaluation the formation of ovary mass by sonography up to one year after transplantation (patient will follow for any adverse event via follow up visits (24hr after transplantation, 1th , 2th , 4th , 8th , 12th week , 6th month and 12th month after cell transplantation.
Measured: up to 12months
ovary abcess
Evaluation the ovary abcess formation up to one year after transplantation (patient will follow for any adverse event via follow up visits (24hr after transplantation, 1th , 2th , 4th , 8th , 12th week , 6th month and 12th month after cell transplantation.
Measured: Up to 12 months
Secondary outcomes (6)
Follicle Stimulating Hormone (FSH) serum level
one year after transplantation (patient will follow for any adverse event via one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Measured: Up to 12months
Anti-Mullerian Hormone (AMH) serum level
Evaluation the AMH serum level by blood sampling up to one year after transplantation (patient will follow for any adverse event via one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Measured: Up to 12months
Number of antral follicle
Evaluation the number of antral follicle by sonography up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Measured: Up to 12months
Antral follicle volume
Evaluation the antral follicle volume by sonography up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Measured: Up to 12months
Menstruation recurrence rate
Evaluation the menstruation recurrence rate up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Measured: Up to 12 months
Pregnancy rate
Evaluation the pregnancy rate up to one year after transplantation ( this measures will evaluate within follow up visits at 1th , 2th , 4th, 8th, 12th weeks and 6th and 12th month after transplantation
Measured: Up to 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteTahereh Madani, MD, Study director, Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.Mehri Mashayekhi, MD, Study director, Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.Elham sadat Mirzadeh, MD, Principal investigator, Department of Regenerative Medicin, Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603744
- Sponsor's protocol ID
- Rep-Bio-Royan-001
- Status last verified
- Apr 2017
- First submitted
- 7 Nov 2015
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mashayekhi M, Mirzadeh E, Chekini Z, Ahmadi F, Eftekhari-Yazdi P, Vesali S, Madani T, Aghdami N. Evaluation of safety, feasibility and efficacy of intra-ovarian transplantation of autologous adipose derived mesenchymal stromal cells in idiopathic premature ovarian failure patients: non-randomized clinical trial, phase I, first in human. J Ovarian Res. 2021 Jan 6;14(1):5. doi: 10.1186/s13048-020-00743-3.
PubMed 33407794
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Feasibility of Intra-ovarian Injection of Autologous Adipose Derived Mesenchymal Stromal Cells (ADMSC) in Women With Premature Ovarian Failure(POF)
- ClinicalTrials.gov ID
- NCT02603744
- Acronym / sponsor ID
- Rep-Bio-Royan-001
- Conditions
- Premature Ovarian Failure
- Keywords
- Premature ovarian failure adipose derived stromal cells intraovarian injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 million MSC | Experimental | Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells. |
| 10 million MSC | Experimental | Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells. |
| 15 million MSC | Experimental | Biological: Intraovarian injection of Adipose derived Stromal cells (ADSCs)The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female
- Age : 20-39
- FSH>20
Key exclusion criteria (6 listed)
- liposuction contraindication
- thyroid dysfunction
- immune system disease
- past history of cancer , chemotherapy , radiotherapy
- HIV+, hepatitis B, C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraovarian injection of Adipose derived Stromal cells (ADSCs)Also: stem cell transplantationIntra-ovarian injection of Adipose derived mesenchymal stem cells. | Biological | 10 million MSC, 15 million MSC, 5 million MSC |
Primary outcome
ovary mass
Time frame: up to 12months
Evaluation the formation of ovary mass by sonography up to one year after transplantation (patient will follow for any adverse event via follow up visits (24hr after transplantation, 1th , 2th , 4th , 8th , 12th week , 6th month and 12th month after cell transplantation.
ovary abcess
Time frame: Up to 12 months
Evaluation the ovary abcess formation up to one year after transplantation (patient will follow for any adverse event via follow up visits (24hr after transplantation, 1th , 2th , 4th , 8th , 12th week , 6th month and 12th month after cell transplantation.
6 secondary outcomes
Follicle Stimulating Hormone (FSH) serum level
Time frame: Up to 12months
Anti-Mullerian Hormone (AMH) serum level
Time frame: Up to 12months
Number of antral follicle
Time frame: Up to 12months
Antral follicle volume
Time frame: Up to 12months
Menstruation recurrence rate
Time frame: Up to 12 months
Pregnancy rate
Time frame: Up to 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Derived from this study: PubMed 33407794Mashayekhi M, Mirzadeh E, Chekini Z, Ahmadi F, Eftekhari-Yazdi P, Vesali S, Madani T, Aghdami N. Evaluation of safety, feasibility and efficacy of intra-ovarian transplantation of autologous adipose derived mesenchymal stromal cells in idiopathic premature ovarian failure patients: non-randomized clinical trial, phase I, first in human. J Ovarian Res. 2021 Jan 6;14(1):5. doi: 10.1186/s13048-020-00743-3.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Tahereh Madani, MD study director
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Mehri Mashayekhi, MD study director
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intraovarian injection of Adipose derived Stromal cells (ADSCs) in people with Premature Ovarian Failure, run by Royan Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser Aghdami, MD, PhD ((+98)23562000 ext. 516, nasser.aghdami@royaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ovary mass (time frame: up to 12months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02603744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.