Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Tissue Expansion and Skin Regeneration
Recruitment status was: Recruiting
|Tissue Expansion; Skin Regeneration; Reconstruction; Bone Marrow Mononuclear Cells||Procedure: Autologous bone marrow mononuclear cells Procedure: Placebo||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase 1/2 Study of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Soft Tissue Expansion|
- 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 ]
- 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 ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Autologous bone marrow mononuclear cells
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).
Procedure: Autologous bone marrow mononuclear cells
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.
Placebo Comparator: Saline
Patient has intradermally and subcutaneously injection of saline.
Patients will have mimical bone marrow aspiration under local anesthesia following with saline injection to expanded skin.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209611
|Contact: Qingfeng Li, MD, PhD||0086 21 firstname.lastname@example.org|
|Contact: Shuangbai Zhou, MD||0086 email@example.com|
|Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200011|
|Contact: Qingfeng Li, MD, PhD 0086 21 63089567 firstname.lastname@example.org|
|Contact: Shuangbai Zhou, MD 0086 13482514585 email@example.com|
|Principal Investigator: Qingfeng Li, MD, PhD|
|Sub-Investigator: Shuangbai Zhou, MD|
|Sub-Investigator: Tao Zan, MD, PhD|
|Study Director:||Qingfeng Li, MD, PhD||Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine|