Parathyroid Allo-transplantationNCT02134483
Parathyroid Allo-transplantation With a New Technique
A study testing Parathyroid allo-transplantation in people with Parathyroid Allo-transplantation, run by Erhan Aysan at 1 site in Turkey (Türkiye).
Trial summary
Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of permanent hypoparathyroidism. However, it is a difficult process that requires a number of trained staff and advanced laboratory equipment which bring high costs. In this study, we have identified a new PA-t technique. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Parathyroid Allo-transplantation
- What is being tested?
- Parathyroid allo-transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2013to 1 Dec 2015
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have permanent hypocalcemia
- Patients who accept to participate to study
Who cannot join
- -Patients who don't accept to participate to study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Istanbul, 34093
About this study
Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of permanent hypoparathyroidism. However, it is a difficult process that requires a number of trained staff and advanced laboratory equipment which bring high costs. In this study, we have identified a new PA-t technique.
Read the detailed description
Hypoparathyroidism is a clinical problem which is associated with hypocalcemia, hyperphosphatemia, low parathyroid hormone levels and often manifests itself as a complication of thyroid surgery . Direct injury, ischemia or unintended excision of parathyroid tissue are the most common mechanisms that cause temporary or permanent hypoparathyroidism. Temporary hypoparathyroidism (<6 months) develops at 10% of cases after thyroid surgery and nearly half of them develops permanent hypoparathyroidism (>6 months) (3-5). Due to the rapid increase in thyroid cancer cases in recent years, total thyroidectomy and neck dissection is performed more frequently than before that yields increase in frequency of permanent hypoparathyroidism.
As a current standard treatment, oral or intravenous calcium preparations and active vitamin-D3 are used in the treatment of hypocalcemia which was developed due to permanent hypoparathyroidism (PH). However, this approach is a symptomatic treatment, must continue a lifetime, the cost is high and is only intended to correct hypocalcemia. Besides, it has no beneficial effect on metabolic problems due to PH.
For these reasons, less costly and effective treatments have been searched over 30 years and parathyroid allo-transplantation (PA-t) was introduced as a treatment alternative. Nonetheless, it did not meet the expectations completely. The main problem in PA-t is the development of immune and inflammatory response against graft tissue which shortens its life and impairs the efficacy of the treatment. Various kinds of treatment methods such as immunosuppression, microencapsulation and cultivation were tried to overcome this problem. Despite these treatment options, convincing results have not yet been achieved . In literature, PA-t cases are often presented as case reports, only a few clinical series are available .
In this study, we aimed to present the results of our new PA-t technique that is performed on 10 patients who were diagnosed as permanent hypocalcemia following thyroid surgery and had no benefit from standard medical therapy
- Conditions
- Parathyroid Allo-transplantation
- Being tested
- Parathyroid allo-transplantation
- Keywords
- Parathyroid, Permanent hypocalcemia, Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parathyroid allo-transplantationBiological
parathyroid allotransplantation with a new tecnique without immunosuppression
| Study group | Role | What they receive |
|---|---|---|
| Parathyroid allo-transplantation | Experimental | patients who have permanent hypoparatyroidism Receives: Biological: Parathyroid allo-transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
to mesure patient's blood calcium
Measured: up to three months
Secondary outcomes (1)
to mesure patient's parathormon levels
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study start1 Sep 2013
- Primary completion1 May 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parathyroid Allo-transplantationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erhan Aysan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erhan Aysan, SB Istanbul Education and Research Hospital
- Investigators
- erhan aysan, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134483
- Sponsor's protocol ID
- 1234567
- Other IDs
- 79797979
- Status last verified
- Feb 2017
- First submitted
- 1 May 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parathyroid Allo-transplantation With a New Technique
- ClinicalTrials.gov ID
- NCT02134483
- Acronym / sponsor ID
- 1234567
- Conditions
- Parathyroid Allo-transplantation
- Keywords
- Parathyroid, Permanent hypocalcemia, Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Erhan AysanUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 9 May 2014 (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.
Parathyroid allo-transplantation (PA-t) is a valuable alternative in the treatment of permanent hypoparathyroidism. However, it is a difficult process that requires a number of trained staff and advanced laboratory equipment which bring high costs. In this study, we have identified a new PA-t technique.
Detailed description
Hypoparathyroidism is a clinical problem which is associated with hypocalcemia, hyperphosphatemia, low parathyroid hormone levels and often manifests itself as a complication of thyroid surgery . Direct injury, ischemia or unintended excision of parathyroid tissue are the most common mechanisms that cause temporary or permanent hypoparathyroidism. Temporary hypoparathyroidism (<6 months) develops at 10% of cases after thyroid surgery and nearly half of them develops permanent hypoparathyroidism (>6 months) (3-5). Due to the rapid increase in thyroid cancer cases in recent years, total thyroidectomy and neck dissection is performed more frequently than before that yields increase in frequency of permanent hypoparathyroidism.
As a current standard treatment, oral or intravenous calcium preparations and active vitamin-D3 are used in the treatment of hypocalcemia which was developed due to permanent hypoparathyroidism (PH). However, this approach is a symptomatic treatment, must continue a lifetime, the cost is high and is only intended to correct hypocalcemia. Besides, it has no beneficial effect on metabolic problems due to PH.
For these reasons, less costly and effective treatments have been searched over 30 years and parathyroid allo-transplantation (PA-t) was introduced as a treatment alternative. Nonetheless, it did not meet the expectations completely. The main problem in PA-t is the development of immune and inflammatory response against graft tissue which shortens its life and impairs the efficacy of the treatment. Various kinds of treatment methods such as immunosuppression, microencapsulation and cultivation were tried to overcome this problem. Despite these treatment options, convincing results have not yet been achieved . In literature, PA-t cases are often presented as case reports, only a few clinical series are available .
In this study, we aimed to present the results of our new PA-t technique that is performed on 10 patients who were diagnosed as permanent hypocalcemia following thyroid surgery and had no benefit from standard medical therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parathyroid allo-transplantation | Experimental | Biological: Parathyroid allo-transplantationpatients who have permanent hypoparatyroidism |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who have permanent hypocalcemia
- Patients who accept to participate to study
Key exclusion criteria (1 listed)
- -Patients who don't accept to participate to study
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 |
|---|---|---|
| Parathyroid allo-transplantationparathyroid allotransplantation with a new tecnique without immunosuppression | Biological | Parathyroid allo-transplantation |
Primary outcome
to mesure patient's blood calcium
Time frame: up to three months
1 secondary outcome
to mesure patient's parathormon levels
Time frame: up to three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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.
erhan aysan principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parathyroid allo-transplantation in people with Parathyroid Allo-transplantation, run by Erhan Aysan at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 23 Feb 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to mesure patient's blood calcium (time frame: up to three months). 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 23 Feb 2017.