Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Tissue Expansion and Skin Regeneration

Bone Marrow Mononuclear Cells Clinical Trial

Official title:

Phase 1/2 Study of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Soft Tissue Expansion

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01209611
• Other study ID #: 30730092
• Status: Unknown status
• Phase: Phase 1/Phase 2
• First received: September 2, 2010
• Last updated: April 21, 2014
• Start date: September 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Qingfeng Li, MD, PhD
• Phone: 0086 21 63089567
• Email: liqfliqf[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;

• History of allogenic bone marrow transplantation;

• Long history of smoking;

• Evidence of malignant diseases or unwillingness to participate.

Related Conditions & MeSH terms

• Bone Marrow Mononuclear Cells
• Reconstruction;
• Skin Regeneration;
• Tissue Expansion;

Intervention

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
Patients will have mimical bone marrow aspiration under local anesthesia following with saline injection to expanded skin.

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To measure inflation volume of the silicone expander		baseline, 4 weeks and 8 weeks post treatment
Secondary	To measure the size of expanded flap		baseline and 8 weeks post treatment
Secondary	To measure the texture of expanded flap		4 weeks and 8 weeks post treatment
Secondary	To measure expanded skin thickness by ultrasound scanning		baseline, 4 weeks and 8 weeks post treatment
Secondary	Laboratory examinations including routine blood test, liver function and renal function		baseline and 8 weeks post stem cell transplantation