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

NCT01209611 | Unknown Phase 1

• 1 other identifier: 30730092
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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

  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

Study Arms (2)

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).

Procedure: Autologous bone marrow mononuclear cells

Saline

PLACEBO COMPARATOR

Patient has intradermally and subcutaneously injection of saline.

Procedure: Placebo

Interventions

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.

Autologous bone marrow mononuclear cells

Placebo PROCEDURE

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

Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 27876353 DERIVED

Study Officials

• Qingfeng Li, MD, PhD

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

  STUDY DIRECTOR

Central Study Contacts

Qingfeng Li, MD, PhD

CONTACT

0086 21 63089567; liqfliqf@yahoo.com.cn

Shuangbai Zhou, MD

CONTACT

0086 13482514585; shuangbaizhou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, Head of the Department of Plastic and Reconstructive Surgery, Shanghai 9th People'sHospital

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 27, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2014
• Last Updated: April 22, 2014

Record last verified: 2014-04

Locations

CN (1)