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

NCT ID: NCT01209611

Last Updated: 2014-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-12-31

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Autologous bone marrow mononuclear cells

Intervention Type: 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.

Saline

Patient has intradermally and subcutaneously injection of saline.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Placebo

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Qing-Feng Li

MD, PhD, Professor, Head of the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingfeng Li, MD, PhD

Role: STUDY_DIRECTOR

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Locations

Shanghai Ninth People's Hospital, Affliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qingfeng Li, MD, PhD

Role: CONTACT

liqfliqf@yahoo.com.cn

0086 21 63089567

Shuangbai Zhou, MD

Role: CONTACT

shuangbaizhou@gmail.com

0086 13482514585

Facility Contacts

Qingfeng Li, MD, PhD

Role: primary

liqfliqf@yahoo.com.cn

0086 21 63089567

Shuangbai Zhou, MD

Role: backup

shuangbaizhou@gmail.com

0086 13482514585

References

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.

Reference Type: DERIVED

PMID: 27876353 (View on PubMed)

Other Identifiers

30730092

Identifier Type: -

Identifier Source: org_study_id