Nonunion FracturePhase 1/2NCT03031509
Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
A Phase 1/2 study testing Human Amniotic Epithelial Cells and debridement in people with Nonunion Fracture, run by Shanghai East Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial cells transplant in nonunion of limb fracture patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nonunion Fracture
- What is being tested?
- Human Amniotic Epithelial Cells and debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Dec 2017to 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with nonunion of limbs by x-ray and bone scan;
- compliance to treatment and long term follow-up;
- be able and willing to participate in the study;
- written informed consent before study.
Who cannot join
- pregnant or breastfeeding;
- patients with malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppressant therapy ( chemotherapy or steroids), OR health status, mental diseases, which will influence the study;
- patients undergoing any other treatment that are not related to this study;
- others considered not appropriate selected patients.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai East Hospital
Shanghai, 021
LIN LI, 86-021-61569006 ext. 9829
About this study
The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial cells transplant in nonunion of limb fracture patients.
Read the detailed description
In this study, patients of nonunion after limb fracture will be treated with human amniotic epithelial cells. Clinical and radiological assessment is performed.
hAECs developing from the epiblast as early as 8 days after fertilization, recent data reported indicate that hAECs possess proper osteogenic differentiation potential and a localized modulatory influence on the early tissue remodeling process, making these cells a promising stem cell source for bone regeneration after fractures.
- Conditions
- Nonunion Fracture
- Being tested
- Human Amniotic Epithelial Cells, debridement
- Keywords
- Nonunion Fracture of limb
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Amniotic Epithelial CellsBiological
Human Amniotic Epithelial Cells transplant after debridement
debridementProcedure or surgery
debridement
| Study group | Role | What they receive |
|---|---|---|
| hAECs treatment | Experimental | Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery Receives: Biological: Human Amniotic Epithelial Cells; Procedure: debridement |
| debridement surgery | Sham comparator | debridement surgery Receives: Procedure: debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
time for bone union
Bone union was evaluated at 6-month after surgery according to the following definition.Definition of bone union is when simple X-ray findings reveal that bone trabeculae or cortical bone exceeds the fracture site.
Measured: 6 months
Secondary outcomes (2)
pain in fracture site
Measured: 1 year
limb functional score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startDec 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nonunion FractureStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Responsible party
- Sponsor
- Investigators
- XIA LI, Dr., Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031509
- Sponsor's protocol ID
- DFSC-2017（CR）-01
- Status last verified
- Jun 2017
- First submitted
- 23 Jan 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Miki T, Lehmann T, Cai H, Stolz DB, Strom SC. Stem cell characteristics of amniotic epithelial cells. Stem Cells. 2005 Nov-Dec;23(10):1549-59. doi: 10.1634/stemcells.2004-0357. Epub 2005 Aug 4.
PubMed 16081662Si J, Dai J, Zhang J, Liu S, Gu J, Shi J, Shen SG, Guo L. Comparative investigation of human amniotic epithelial cells and mesenchymal stem cells for application in bone tissue engineering. Stem Cells Int. 2015;2015:565732. doi: 10.1155/2015/565732. Epub 2015 Mar 5.
PubMed 25834575Jiawen S, Jianjun Z, Jiewen D, Dedong Y, Hongbo Y, Jun S, Xudong W, Shen SG, Lihe G. Osteogenic differentiation of human amniotic epithelial cells and its application in alveolar defect restoration. Stem Cells Transl Med. 2014 Dec;3(12):1504-13. doi: 10.5966/sctm.2014-0118. Epub 2014 Nov 3.
PubMed 25368378
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
- ClinicalTrials.gov ID
- NCT03031509
- Acronym / sponsor ID
- DFSC-2017（CR）-01
- Conditions
- Nonunion Fracture
- Keywords
- Nonunion Fracture of limb
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Study start
- Dec 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Jan 2017 (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 evaluate the efficacy and safety of human amniotic epithelial cells transplant in nonunion of limb fracture patients.
Detailed description
In this study, patients of nonunion after limb fracture will be treated with human amniotic epithelial cells. Clinical and radiological assessment is performed.
hAECs developing from the epiblast as early as 8 days after fertilization, recent data reported indicate that hAECs possess proper osteogenic differentiation potential and a localized modulatory influence on the early tissue remodeling process, making these cells a promising stem cell source for bone regeneration after fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hAECs treatment | Experimental | Biological: Human Amniotic Epithelial Cells, Procedure: debridementHuman Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery |
| debridement surgery | Sham comparator | Procedure: debridementdebridement surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with nonunion of limbs by x-ray and bone scan;
- compliance to treatment and long term follow-up;
- be able and willing to participate in the study;
- written informed consent before study.
Key exclusion criteria (4 listed)
- pregnant or breastfeeding;
- patients with malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppressant therapy ( chemotherapy or steroids), OR health status, mental diseases, which will influence the study;
- patients undergoing any other treatment that are not related to this study;
- others considered not appropriate selected patients.
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 Amniotic Epithelial CellsHuman Amniotic Epithelial Cells transplant after debridement | Biological | hAECs treatment |
| debridementdebridement | Procedure or surgery | debridement surgery, hAECs treatment |
Primary outcome
time for bone union
Time frame: 6 months
Bone union was evaluated at 6-month after surgery according to the following definition.Definition of bone union is when simple X-ray findings reveal that bone trabeculae or cortical bone exceeds the fracture site.
2 secondary outcomes
pain in fracture site
Time frame: 1 year
limb functional score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Background: PubMed 16081662Miki T, Lehmann T, Cai H, Stolz DB, Strom SC. Stem cell characteristics of amniotic epithelial cells. Stem Cells. 2005 Nov-Dec;23(10):1549-59. doi: 10.1634/stemcells.2004-0357. Epub 2005 Aug 4.
- Background: PubMed 25834575Si J, Dai J, Zhang J, Liu S, Gu J, Shi J, Shen SG, Guo L. Comparative investigation of human amniotic epithelial cells and mesenchymal stem cells for application in bone tissue engineering. Stem Cells Int. 2015;2015:565732. doi: 10.1155/2015/565732. Epub 2015 Mar 5.
- Background: PubMed 25368378Jiawen S, Jianjun Z, Jiewen D, Dedong Y, Hongbo Y, Jun S, Xudong W, Shen SG, Lihe G. Osteogenic differentiation of human amniotic epithelial cells and its application in alveolar defect restoration. Stem Cells Transl Med. 2014 Dec;3(12):1504-13. doi: 10.5966/sctm.2014-0118. Epub 2014 Nov 3.
- 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.
XIA LI, Dr. principal investigator
Shanghai East Hospital
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 Amniotic Epithelial Cells and debridement in people with Nonunion Fracture, run by Shanghai East 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 4 inclusion and 4 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 Jun 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. Some participants in this study may receive a placebo. 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 Xia LI, Dr. (86-21-38804518 ext. 14185, daxia868@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time for bone union (time frame: 6 months). 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 NCT03031509, which also lists 3 linked publications.
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 Jun 2017.