Tissue Expansion;Phase 1/2NCT01209611
Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Tissue Expansion and Skin Regeneration
A Phase 1/2 study testing Autologous bone marrow mononuclear cells in people with Tissue Expansion; and Skin Regeneration;, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluating whether autologous bone marrow mononuclear cells transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tissue Expansion;, Skin Regeneration;, Reconstruction;
- What is being tested?
- Autologous bone marrow mononuclear cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18 to 60 years;
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Implanted silicone expander of 80 to 600 ml in size;
- History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- Persistent high level of expander internal pressure;
- Need for further skin expansion;
Who cannot join
- Not fit for soft tissue expansion treatment;
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or 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;
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- History of allogenic bone marrow transplantation;
- Long history of smoking;
- Evidence of malignant diseases or unwillingness to participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Qingfeng Li, MD, PhD, 0086 21 63089567, liqfliqf@yahoo.com.cn
Shuangbai Zhou, MD, 0086 13482514585, shuangbaizhou@gmail.com
About this study
Official title: Phase 1/2 Study of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Soft Tissue Expansion
The purpose of this study is to evaluating whether autologous bone marrow mononuclear cells transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.
Read the detailed description
Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. Although, on some occasions, decelerating the expander inflation process could reduce the incidence of necrosis, this prolonged therapy circle is to be accompanied with increased complications, including infection and expander rupture, as well as the increased economic expenses by the longer hospitalization. This study is to observe the effects of autologous bone marrow mononuclear cell transplantation on accelerating skin regeneration and promoting tissue expansion process.
Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into two groups, named as the experimental group and the control group. Patients from the experimental group will have a bone marrow aspiration and intradermal mononuclear cells transplantation. On the other side, Patients from the control group will have saline injection.
- Being tested
- Autologous bone marrow mononuclear cells, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow mononuclear cellsProcedure or surgery
Autologous bone marrow-derived mononuclear cells, after isolated by density gradient centrifugation from bone marrow aspiration and resuspended in saline, will be transplanted subcutaneously to expanded skin. The number of infused cells will be 1x10e6/cm2.
PlaceboProcedure or surgery
Patients will have mimical bone marrow aspiration under local anesthesia following with saline injection to expanded skin.
| Study group | Role | What they receive |
|---|---|---|
| Autologous bone marrow mononuclear cells | Experimental | Patients received autologous MNC transplantation. Bone marrow aspirates are harvested from the anterior iliac crest of the patients under general or local anesthesia. MNCs are isolated by density gradient centrifugation. The cell suspension was adjusted to a final volume of 6-20 ml with saline. The cell suspension was injected into expanded skin intradermally via a 27-gauge needle (approximately 0.5-1×10^6 cells/cm2). Receives: Procedure: Autologous bone marrow mononuclear cells |
| Saline | Placebo comparator | Patient has intradermally and subcutaneously injection of saline. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of major adverse events
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
Measured: Up to approximately 24 months after study start
To measure inflation volume of the silicone expander
Measured: baseline, 4 weeks and 8 weeks post treatment
Secondary outcomes (4)
To measure the size of expanded flap
Measured: baseline and 8 weeks post treatment
To measure the texture of expanded flap
Measured: 4 weeks and 8 weeks post treatment
To measure expanded skin thickness by ultrasound scanning
Measured: baseline, 4 weeks and 8 weeks post treatment
Laboratory examinations including routine blood test, liver function and renal function
Measured: baseline and 8 weeks post stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2013
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tissue Expansion;Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209611
- Sponsor's protocol ID
- 30730092
- Status last verified
- Apr 2014
- First submitted
- 2 Sep 2010
- Last updated
- 22 Apr 2014
- Results posted
- No
Publications
Zhou SB, Zhang GY, Xie Y, Zan T, Gan YK, Yao CA, Chiang CA, Wang J, Liu K, Li H, Zhou J, Yang M, Gu B, Xie F, Pu LQ, Magee WP 3rd, Li QF. Autologous Stem Cell Transplantation Promotes Mechanical Stretch Induced Skin Regeneration: A Randomized Phase I/II Clinical Trial. EBioMedicine. 2016 Nov;13:356-364. doi: 10.1016/j.ebiom.2016.09.031. Epub 2016 Oct 1.
PubMed 27876353
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Soft Tissue Expansion
- ClinicalTrials.gov ID
- NCT01209611
- Acronym / sponsor ID
- 30730092
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Sep 2010 (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 evaluating whether autologous bone marrow mononuclear cells transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.
Detailed description
Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. Although, on some occasions, decelerating the expander inflation process could reduce the incidence of necrosis, this prolonged therapy circle is to be accompanied with increased complications, including infection and expander rupture, as well as the increased economic expenses by the longer hospitalization. This study is to observe the effects of autologous bone marrow mononuclear cell transplantation on accelerating skin regeneration and promoting tissue expansion process.
Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into two groups, named as the experimental group and the control group. Patients from the experimental group will have a bone marrow aspiration and intradermal mononuclear cells transplantation. On the other side, Patients from the control group will have saline injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous bone marrow mononuclear cells | Experimental | Procedure: Autologous bone marrow mononuclear cellsPatients received autologous MNC transplantation. Bone marrow aspirates are harvested from the anterior iliac crest of the patients under general or local anesthesia. MNCs are isolated by density gradient centrifugation. The cell suspension was adjusted to a final volume of 6-20 ml with saline. The cell suspension was injected into expanded skin intradermally via a 27-gauge needle (approximately 0.5-1×10^6 cells/cm2). |
| Saline | Placebo comparator | Procedure: PlaceboPatient has intradermally and subcutaneously injection of saline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age of 18 to 60 years;
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Implanted silicone expander of 80 to 600 ml in size;
- History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- Persistent high level of expander internal pressure;
Key exclusion criteria (9 listed)
- Not fit for soft tissue expansion treatment;
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or 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 |
|---|---|---|
| Autologous bone marrow mononuclear cellsAutologous bone marrow-derived mononuclear cells, after isolated by density gradient centrifugation from bone marrow aspiration and resuspended in saline, will be transplanted subcutaneously to expanded skin. The number of infused cells will be 1x10e6/cm2. | Procedure or surgery | Autologous bone marrow mononuclear cells |
| PlaceboPatients will have mimical bone marrow aspiration under local anesthesia following with saline injection to expanded skin. | Procedure or surgery | Saline |
Primary outcome
Occurence of major adverse events
Time frame: Up to approximately 24 months after study start
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
To measure inflation volume of the silicone expander
Time frame: baseline, 4 weeks and 8 weeks post treatment
4 secondary outcomes
To measure the size of expanded flap
Time frame: baseline and 8 weeks post treatment
To measure the texture of expanded flap
Time frame: 4 weeks and 8 weeks post treatment
To measure expanded skin thickness by ultrasound scanning
Time frame: baseline, 4 weeks and 8 weeks post treatment
Laboratory examinations including routine blood test, liver function and renal function
Time frame: baseline and 8 weeks post stem cell transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
- Derived from this study: PubMed 27876353Zhou SB, Zhang GY, Xie Y, Zan T, Gan YK, Yao CA, Chiang CA, Wang J, Liu K, Li H, Zhou J, Yang M, Gu B, Xie F, Pu LQ, Magee WP 3rd, Li QF. Autologous Stem Cell Transplantation Promotes Mechanical Stretch Induced Skin Regeneration: A Randomized Phase I/II Clinical Trial. EBioMedicine. 2016 Nov;13:356-364. doi: 10.1016/j.ebiom.2016.09.031. Epub 2016 Oct 1.
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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
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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 Autologous bone marrow mononuclear cells in people with Tissue Expansion; and Skin Regeneration;, 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 6 inclusion and 9 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 22 Apr 2014. 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 Qingfeng Li, MD, PhD (0086 21 63089567, liqfliqf@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of major adverse events (time frame: Up to approximately 24 months after study start). 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?
On the ClinicalTrials.gov record for NCT01209611, which also lists 1 linked publication.
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 22 Apr 2014; AzTrials last refreshed its copy on 6 Nov 2026.