Bone DefectPhase 1/2NCT02748343
The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone
A Phase 1/2 study testing allograft bone and tissue-engineered bone in people with Bone Defect and Bone Nonunion, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare use of a tissue-engineered bone to use of a standard allograft bone to treat bone defect in patients. The hypothesis is that use of the tissue-engineered bone is effective and safe to treat the bone defect in patients. Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Bone Defect, Bone Nonunion
- What is being tested?
- allograft bone and tissue-engineered bone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Dec 2020
- 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 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- the patients with bone defect and bone nonunion caused by tumor or trauma
- the length of bone defect in long diaphysis is more than 4cm or more than half of the shaft diameter
- the size of bone defect is more than 5cmx5cm
- the patients are unable to use autologous bone graft or other treatments
- the patients request to use the treatment of tissue-engineered bone
- Supportive family with willingness to participate in completing questionnaires
Who cannot join
- Patients with serious diseases such as hemorrhagic disorders, infection, tumor, contagion and so on.
- Patients who are pregnant
- Patients with serious abnormal cardiopulmonary function
- Patients disagree to use the tissue-engineered bone
- Patients are older than 60 years
- Patients who are regarded to be unqualified by investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Orthopedics, Xijing Hospital, The Fourth Military Medical University
Xi’an, Shanxi, 710032
long bi, MD,PHD, +86 02984773524, bilong@fmmu.edu.cn
About this study
The purpose of this study is to compare use of a tissue-engineered bone to use of a standard allograft bone to treat bone defect in patients. The hypothesis is that use of the tissue-engineered bone is effective and safe to treat the bone defect in patients.
Read the detailed description
Patients with the bone defect without infection and sever system diseases will be recruited.
The material selected as the scaffold for this study will be a porous β-tricalcium phosphate scaffold (β-TCP) scaffold and scaffold is custom-made according to the size and shape of bone defect after three-dimensional CT scan. Human BMSCs will be obtained and cultured before operation and 3.4×106 cells in 10ml serum-free medium will be seeded onto scaffold to construct the tissue engineered bone graft and co-cultured for two weeks.
The implant operation will be carried out under the general anesthesia. The tissue engineered bone graft will be implanted into the bone defect area. The bone defect area will be covered with surrounding soft tissue and muscle to close the wound. Anti-inflammatory, repercussive and analgesic drugs will be used for 1 week.
Patient will be hospitalized for 1 to 2 weeks after surgery. Blood routine examination, erythrocyte sedimentation rate, immunoglobulin, autoantibodies and clinical examination will be carried out for signs of pain, swelling, immune rejection and infection. Patient will be evaluated at 3 days，3, 6, 12, 18 and 22 months after operation by radiography; Three-dimensional CT scan will be also performed at regular intervals. The function of the body will be evaluated at regular intervals.
- Conditions
- Bone Defect, Bone Nonunion
- Being tested
- allograft bone, tissue-engineered bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allograft boneDevice
Use of the allograft bone to treat the bone defect in patients
tissue-engineered boneDevice
Use of the tissue-engineered bone to treat the bone defect in patients
| Study group | Role | What they receive |
|---|---|---|
| allograft bone | Active comparator | traditional allograft bone Receives: Device: allograft bone |
| tissue-engineered bone | Experimental | tissue-engineered bone Receives: Device: tissue-engineered bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The scores of bone healing
The scores of bone healing are divided into three kinds: nonhealing: 0; delayed healing: 1; normal healing: 2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
the adverse event incidence using tissue-engineered bone and allograft bone
the adverse event incidence of tissue-engineered bone is compared with the adverse event incidence of allograft bone to verify the safety of tissue-engineered bone.
Measured: within 24 weeks after surgical treatment of bone dect
Secondary outcomes (12)
The scores of blood routine test
The scores of blood routine test after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
The scores of erythrocyte sedimentation rate(ESR)
The scores of erythrocyte sedimentation rate (ESR) after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
The scores of C-reactive protein
The scores of C-reaction protein after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
The scores of the ratio of complement C3 to complement C4
The scores of ratio of complement C3 to C4 after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
The scores of immunoglobulin assay
The scores of immunoglobulin assay (IgG, IgA and IgM) after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
The scores of duration of hospital stay
The scores of duration of hospital stay are divided into four kinds: longer than one months: 0; longer than two weeks:1; longer than one week:2; less than one week:3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
the scores of time of weight loading after operation
The scores of time of weight loading after operation are divided into three kinds: longer than six months: 0; longer than three months:1; less than three months:2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
The scores of tumorigenesis
The scores of tumorigenesis after operation are divided into three kinds: severely abnormal：0；abnormal：1；normal：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
The scores of treatment course
The scores of treatment course are divided into three kinds: long：0；general ：1；short：2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
The scores of number of operations
The scores of number of operations are divided into four kinds: above three times：0； three times：1；two times：2；one time：3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
The scores of pain
The scores of pain after operation are divided into four kinds: severe:0;moderate:1;slight:2; none:3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
The scores of wound healing of soft tissue
The scores of wound healing are divided into four kinds: infection: 0; no healing: 1; delayed healing: 2; normal healing: 3. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
Measured: within 48 weeks after surgical treatment of bone dect
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startNov 2014
- Primary completionSep 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DefectStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748343
- Sponsor's protocol ID
- bilong11
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone
- ClinicalTrials.gov ID
- NCT02748343
- Acronym / sponsor ID
- bilong11
- Conditions
- Bone Defect, Bone Nonunion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Apr 2016 (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 compare use of a tissue-engineered bone to use of a standard allograft bone to treat bone defect in patients. The hypothesis is that use of the tissue-engineered bone is effective and safe to treat the bone defect in patients.
Detailed description
Patients with the bone defect without infection and sever system diseases will be recruited.
The material selected as the scaffold for this study will be a porous β-tricalcium phosphate scaffold (β-TCP) scaffold and scaffold is custom-made according to the size and shape of bone defect after three-dimensional CT scan. Human BMSCs will be obtained and cultured before operation and 3.4×106 cells in 10ml serum-free medium will be seeded onto scaffold to construct the tissue engineered bone graft and co-cultured for two weeks.
The implant operation will be carried out under the general anesthesia. The tissue engineered bone graft will be implanted into the bone defect area. The bone defect area will be covered with surrounding soft tissue and muscle to close the wound. Anti-inflammatory, repercussive and analgesic drugs will be used for 1 week.
Patient will be hospitalized for 1 to 2 weeks after surgery. Blood routine examination, erythrocyte sedimentation rate, immunoglobulin, autoantibodies and clinical examination will be carried out for signs of pain, swelling, immune rejection and infection. Patient will be evaluated at 3 days，3, 6, 12, 18 and 22 months after operation by radiography; Three-dimensional CT scan will be also performed at regular intervals. The function of the body will be evaluated at regular intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allograft bone | Active comparator | Device: allograft bonetraditional allograft bone |
| tissue-engineered bone | Experimental | Device: tissue-engineered bonetissue-engineered bone |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- the patients with bone defect and bone nonunion caused by tumor or trauma
- the length of bone defect in long diaphysis is more than 4cm or more than half of the shaft diameter
- the size of bone defect is more than 5cmx5cm
- the patients are unable to use autologous bone graft or other treatments
- the patients request to use the treatment of tissue-engineered bone
Key exclusion criteria (6 listed)
- Patients with serious diseases such as hemorrhagic disorders, infection, tumor, contagion and so on.
- Patients who are pregnant
- Patients with serious abnormal cardiopulmonary function
- Patients disagree to use the tissue-engineered bone
- Patients are older than 60 years
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 |
|---|---|---|
| allograft boneUse of the allograft bone to treat the bone defect in patients | Device | allograft bone |
| tissue-engineered boneUse of the tissue-engineered bone to treat the bone defect in patients | Device | tissue-engineered bone |
Primary outcome
The scores of bone healing
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of bone healing are divided into three kinds: nonhealing: 0; delayed healing: 1; normal healing: 2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.
the adverse event incidence using tissue-engineered bone and allograft bone
Time frame: within 24 weeks after surgical treatment of bone dect
the adverse event incidence of tissue-engineered bone is compared with the adverse event incidence of allograft bone to verify the safety of tissue-engineered bone.
12 secondary outcomes
The scores of blood routine test
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of erythrocyte sedimentation rate(ESR)
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of C-reactive protein
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of the ratio of complement C3 to complement C4
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of immunoglobulin assay
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of duration of hospital stay
Time frame: within 48 weeks after surgical treatment of bone dect
the scores of time of weight loading after operation
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of tumorigenesis
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of treatment course
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of number of operations
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of pain
Time frame: within 48 weeks after surgical treatment of bone dect
The scores of wound healing of soft tissue
Time frame: within 48 weeks after surgical treatment of bone dect
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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 allograft bone and tissue-engineered bone in people with Bone Defect and Bone Nonunion, run by Xijing Hospital 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 6 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 17 Nov 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 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 long bi, MD,PHD (+86 02984773524, bilong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The scores of bone healing (time frame: within 48 weeks after surgical treatment of bone dect). 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?
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 17 Nov 2017.