Soft Tissue InfectionsNCT02595047
Autologous Prefabrication of Body Surface Tissues/ Organs(e.g. Joint)
A study testing tissue/ organ prefabrication in people with Soft Tissue Infections and Intentional Self Harm by Other Specified Means, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Infections, Intentional Self Harm by Other Specified Means
- What is being tested?
- tissue/ organ prefabrication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2016
- 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 5 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- With body surface tissue or organ defects (e.g., ear, nose, bone and joint) requiring reconstruction.
Who cannot join
- evidence of infection, ischemia, ulcer or other pathological changes within the prefabricated area which defined as not suitable for tissues regeneration
- history of delayed healing, radiational therapy;
- significant renal, cardiovascular, hepatic and psychiatric diseases;
- significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
- BMI >30;
- history of any hematological disease, including leukopenia, thrombocytopenia, or thrombocytosis;
- Evidence of malignant diseases
- unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Phase 1/2 Study of Autologous Tissues/Body Surface Organs Prefabrication in Tissue Reconstruction
The purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges
Read the detailed description
In the field of tissue regeneration techniques, the in vitro processes and other exogenous factors still have many uncertainties. These uncertainties have hampered road to the clinical application. As the importance of in vivo environment has aroused more awareness, the investigators validated the hypothesis that the feasibility of self-regeneration prefabricated unaided by any in vitro culture process or exogenous elements.
- Being tested
- tissue/ organ prefabrication
- Keywords
- Self-regeneration, in vivo tissue prefabrication,
- Medical subject headings
- Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue/ organ prefabricationProcedure or surgery
Also called ear, joint, bone, cartilage
tissue/ organ is prefabricated in vivo independent of exogenous factors for replacement/ reconstruction purposes
| Study group | Role | What they receive |
|---|---|---|
| tissue/ organ prefabrication | Experimental | in vivo generation of autologous tissue for joint replacement Receives: Procedure: tissue/ organ prefabrication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of major adverse events
Including infection, necrosis, resorption
Measured: through study completion 12 months after prefabrication
Secondary outcomes (1)
Feasibility of self-prefabrication
To observe the regeneration changes of prefabricated neo-tissue by histology (staining) and biomechanical analysis (bone density, Young's modulus)
Measured: 3, 6, and 12 months after prefabrication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InfectionsStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-Feng Li, Shanghai Jiao Tong University School of Medicine
- Investigators
- Qingfeng Li, MD,PhD, Study director, Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595047
- Sponsor's protocol ID
- [2012]23
- Status last verified
- Oct 2015
- First submitted
- 27 Sep 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Autologous Tissues/Body Surface Organs Prefabrication in Tissue Reconstruction
- ClinicalTrials.gov ID
- NCT02595047
- Acronym / sponsor ID
- [2012]23
- Keywords
- Self-regeneration, in vivo tissue prefabrication,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 3 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 purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges
Detailed description
In the field of tissue regeneration techniques, the in vitro processes and other exogenous factors still have many uncertainties. These uncertainties have hampered road to the clinical application. As the importance of in vivo environment has aroused more awareness, the investigators validated the hypothesis that the feasibility of self-regeneration prefabricated unaided by any in vitro culture process or exogenous elements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tissue/ organ prefabrication | Experimental | Procedure: tissue/ organ prefabricationin vivo generation of autologous tissue for joint replacement |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- With body surface tissue or organ defects (e.g., ear, nose, bone and joint) requiring reconstruction.
Key exclusion criteria (8 listed)
- evidence of infection, ischemia, ulcer or other pathological changes within the prefabricated area which defined as not suitable for tissues regeneration
- history of delayed healing, radiational therapy;
- significant renal, cardiovascular, hepatic and psychiatric diseases;
- significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
- BMI >30;
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 |
|---|---|---|
| tissue/ organ prefabricationAlso: ear, joint, bone, cartilagetissue/ organ is prefabricated in vivo independent of exogenous factors for replacement/ reconstruction purposes | Procedure or surgery | tissue/ organ prefabrication |
Primary outcome
Occurence of major adverse events
Time frame: through study completion 12 months after prefabrication
Including infection, necrosis, resorption
1 secondary outcome
Feasibility of self-prefabrication
Time frame: 3, 6, and 12 months after prefabrication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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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.
Qingfeng Li, MD,PhD study director
Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tissue/ organ prefabrication in people with Soft Tissue Infections and Intentional Self Harm by Other Specified Means, run by Shanghai Jiao Tong University School of Medicine 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 1 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 3 Nov 2015. 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.
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?
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?
Occurence of major adverse events (time frame: through study completion 12 months after prefabrication). 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 3 Nov 2015.