Premature Ovarian Failure，Phase 1/2NCT01742533
Stem Cell Therapy Combined Hormone Replacement Therapy in Patients With Premature Ovarian Failure
A Phase 1/2 study testing human umbilical cord mesenchymal stem cells, hUCMSCs and hCBMNCs and human cord blood mononuclear cells in people with Premature Ovarian Failure，, run by Shenzhen Beike Bio-Technology Co., Ltd. at 1 site in China.
Trial summary
Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum gonadotrophins and hypoestrogenism levels in female before the age of 40. It has important physical and psychological consequences/impact in those patients. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Failure，
- What is being tested?
- human umbilical cord mesenchymal stem cells, hUCMSCs and hCBMNCs and human cord blood mononuclear cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Mar 2014
- 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 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between age 18- 39 years, Female only.
- Diagnosed with Premature Ovarian Failure，and currently receiving Hormone Replacement Therapy;
- Willing to sign the Informed Consent Form.
Who cannot join
- Fragile X chromosome.
- polycystic ovary syndrome.
- HIV+.
- Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
- Severe pulmonary and hematological disease, malignancy or hypo-immunity.
- Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
- Pregnancy or lactation
- Enrollment in other trials in the last 3 months. • Other criteria the investigator consider improper for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Fangming Su, 86-755-25533018, sfmlxq@163.com
Fangming Su
About this study
Official title: A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Hormone Replacement Therapy in Patients With Premature Ovarian Failure
Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum gonadotrophins and hypoestrogenism levels in female before the age of 40. It has important physical and psychological consequences/impact in those patients.
Premature ovarian failure (POF) is currently managed by non-physiological sex steroid regimens which are inadequate at optimizing uterine characteristics.
Read more
Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for POF.
In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation combined with Hormone Replacement Therapy will be evaluated in patients with Premature Ovarian Failure. Participants will be followed for an expected average of 48 weeks.
- Conditions
- Premature Ovarian Failure，
- Being tested
- human umbilical cord mesenchymal stem cells, hUCMSCs and hCBMNCs, human cord blood mononuclear cells, Hormone Replacement Therapy
- Keywords
- Hormone Replacement Therapy，, Premature Ovarian Failure，, Stem Cell Therapy
- 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.
human umbilical cord mesenchymal stem cellsBiological
hUCMSCs and hCBMNCsBiological
human cord blood mononuclear cellsBiological
Hormone Replacement TherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Group1 : HRT plus hUCMSCs treatment: | Experimental | Participants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up. Receives: Biological: human umbilical cord mesenchymal stem cells |
| Group 2: HRT plus hCBMNCs and hUCMSCs therapy | Experimental | Participants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up. Receives: Biological: hUCMSCs and hCBMNCs |
| Group3 : HRT plus hCBMNCs treatment: | Experimental | Participants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up. Receives: Biological: human cord blood mononuclear cells |
| Group 4:Hormone Replacement Therapy | Experimental | Participants will be given conventional therapy only with a 12 menstrual Cycle follow-up. Receives: Drug: Hormone Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Level of follicle-stimulating hormone
Measured: 48 weeks after treatment
Secondary outcomes (3)
Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow
Measured: 48 weeks after treatment
Modified Kupperman Score
Measured: 48 weeks after treatment
Incidence of Adverse Events and Serious Adverse Events
Measured: 48 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian Failure，Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742533
- Sponsor's protocol ID
- BKCR-POF-1(Ⅰ)
- Status last verified
- Dec 2012
- First submitted
- 26 Nov 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Hormone Replacement Therapy in Patients With Premature Ovarian Failure
- ClinicalTrials.gov ID
- NCT01742533
- Acronym / sponsor ID
- BKCR-POF-1(Ⅰ)
- Conditions
- Premature Ovarian Failure，
- Keywords
- Hormone Replacement Therapy，, Premature Ovarian Failure，, Stem Cell Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 5 Dec 2012 (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.
Premature ovarian failure (POF) refers the occurrence of amenorrhoea, elevated serum gonadotrophins and hypoestrogenism levels in female before the age of 40. It has important physical and psychological consequences/impact in those patients.
Premature ovarian failure (POF) is currently managed by non-physiological sex steroid regimens which are inadequate at optimizing uterine characteristics.
Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for POF.
In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation combined with Hormone Replacement Therapy will be evaluated in patients with Premature Ovarian Failure. Participants will be followed for an expected average of 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 : HRT plus hUCMSCs treatment: | Experimental | Biological: human umbilical cord mesenchymal stem cellsParticipants will be given HRT plus human cord mesenchymal stem cells transplantation with a 12 menstrual Cycle follow-up. |
| Group 2: HRT plus hCBMNCs and hUCMSCs therapy | Experimental | Biological: hUCMSCs and hCBMNCsParticipants will be given HRT plus combination of hCBMNCs together with hUCMSCs transplantation with a 12 menstrual Cycle follow-up. |
| Group3 : HRT plus hCBMNCs treatment: | Experimental | Biological: human cord blood mononuclear cellsParticipants will be given HRT plus human cord blood mononuclear cells transplantation with a 12 menstrual Cycle follow-up. |
| Group 4:Hormone Replacement Therapy | Experimental | Drug: Hormone Replacement TherapyParticipants will be given conventional therapy only with a 12 menstrual Cycle follow-up. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between age 18- 39 years, Female only.
- Diagnosed with Premature Ovarian Failure，and currently receiving Hormone Replacement Therapy;
- Willing to sign the Informed Consent Form.
Key exclusion criteria (8 listed)
- Fragile X chromosome.
- polycystic ovary syndrome.
- HIV+.
- Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
- Severe pulmonary and hematological disease, malignancy or hypo-immunity.
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 |
|---|---|---|
| human umbilical cord mesenchymal stem cells | Biological | Group1 : HRT plus hUCMSCs treatment: |
| hUCMSCs and hCBMNCs | Biological | Group 2: HRT plus hCBMNCs and hUCMSCs therapy |
| human cord blood mononuclear cells | Biological | Group3 : HRT plus hCBMNCs treatment: |
| Hormone Replacement Therapy | Drug | Group 4:Hormone Replacement Therapy |
Primary outcome
Serum Level of follicle-stimulating hormone
Time frame: 48 weeks after treatment
3 secondary outcomes
Uterine and Ovary characteristics of B ultrasound， including Uterine/Ovarian size and Blood Flow
Time frame: 48 weeks after treatment
Modified Kupperman Score
Time frame: 48 weeks after treatment
Incidence of Adverse Events and Serious Adverse Events
Time frame: 48 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
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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.
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 human umbilical cord mesenchymal stem cells, hUCMSCs and hCBMNCs and human cord blood mononuclear cells in people with Premature Ovarian Failure，, run by Shenzhen Beike Bio-Technology Co., Ltd. at 1 site in China.
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 8 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 5 Dec 2012. 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 China. 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 FangMing Su, Master (86-755-25533018, sfmlxq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Level of follicle-stimulating hormone (time frame: 48 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2012.