Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Saline | Placebo Comparator | Patient has intradermally and subcutaneously injection of saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous bone marrow mononuclear cells | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of major adverse events | Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events | Up to approximately 24 months after study start |
| To measure inflation volume of the silicone expander | baseline, 4 weeks and 8 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the size of expanded flap | baseline and 8 weeks post treatment | |
| To measure the texture of expanded flap | 4 weeks and 8 weeks post treatment | |
| To measure expanded skin thickness by ultrasound scanning |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingfeng Li, MD, PhD | Contact | 0086 21 63089567 | liqfliqf@yahoo.com.cn | |
| Shuangbai Zhou, MD | Contact | 0086 13482514585 | shuangbaizhou@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingfeng Li, MD, PhD | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27876353 | Derived | 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. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 24, 2016 | |
| Reset | Jul 7, 2016 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Procedure | Patients will have mimical bone marrow aspiration under local anesthesia following with saline injection to expanded skin. |
|
| baseline, 4 weeks and 8 weeks post treatment |
| Laboratory examinations including routine blood test, liver function and renal function | baseline and 8 weeks post stem cell transplantation |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 24, 2016 | Jul 7, 2016 |