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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Qing-Feng Li, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01209611
First received: September 2, 2010
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Tissue Expansion;
Skin Regeneration;
Reconstruction;
Bone Marrow Mononuclear Cells
Procedure: Autologous bone marrow mononuclear cells
Procedure: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Occurence of major adverse events [ Time Frame: Up to approximately 24 months after study start ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure the size of expanded flap [ Time Frame: baseline and 8 weeks post treatment ] [ Designated as safety issue: No ]
  • To measure the texture of expanded flap [ Time Frame: 4 weeks and 8 weeks post treatment ] [ Designated as safety issue: No ]
  • To measure expanded skin thickness by ultrasound scanning [ Time Frame: baseline, 4 weeks and 8 weeks post treatment ] [ Designated as safety issue: No ]
  • Laboratory examinations including routine blood test, liver function and renal function [ Time Frame: baseline and 8 weeks post stem cell transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Placebo
Patients will have mimical bone marrow aspiration under local anesthesia following with saline injection to expanded skin.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209611

Contacts
Contact: Qingfeng Li, MD, PhD 0086 21 63089567 liqfliqf@yahoo.com.cn
Contact: Shuangbai Zhou, MD 0086 13482514585 shuangbaizhou@gmail.com

Locations
China, Shanghai
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    liqfliqf@yahoo.com.cn   
Contact: Shuangbai Zhou, MD    0086 13482514585    shuangbaizhou@gmail.com   
Principal Investigator: Qingfeng Li, MD, PhD         
Sub-Investigator: Shuangbai Zhou, MD         
Sub-Investigator: Tao Zan, MD, PhD         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Director: Qingfeng Li, MD, PhD Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  More Information

No publications provided

Responsible Party: Qing-Feng Li, MD, PhD, Professor, Head of the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01209611     History of Changes
Other Study ID Numbers: 30730092
Study First Received: September 2, 2010
Last Updated: April 21, 2014
Health Authority: China: National Natural Science Foundation

ClinicalTrials.gov processed this record on July 31, 2014