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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT01209611

First received: September 2, 2010

Last updated: September 24, 2010

Last verified: September 2010

History of Changes

Purpose

The purpose of this study is to determine 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: 4 weeks post silicone expander implant operation ] [ Designated as safety issue: No ]
To measure inflation volume of the silicone expander [ Time Frame: 8 weeks post silicone expander implant operation ] [ Designated as safety issue: No ]
To measure inflation volume of the silicone expander [ Time Frame: 12 weeks post silicone expander implant operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To measure the size of expanded flap [ Time Frame: baseline ] [ Designated as safety issue: No ]
To measure the size of expanded flap [ Time Frame: 4 weeks post silicone expander implant operation ] [ Designated as safety issue: No ]
To measure the size of expanded flap [ Time Frame: 8 weeks post silicone expander implant operation ] [ Designated as safety issue: No ]
To measure the size of expanded flap [ Time Frame: 12 weeks post silicone expander implant operation ] [ Designated as safety issue: No ]
To measure expanded skin thickness by ultrasound scanning [ Time Frame: baseline and 12 weeks post silicone expander implant operation ] [ Designated as safety issue: No ]
To measure expanded flap contraction after transplantation [ Time Frame: up to 3 months post flap transplant operation ] [ Designated as safety issue: No ]
Laboratory examinations including routine blood test, liver function and renal function [ Time Frame: baseline and 4 weeks post stem cell transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	September 2010
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Autologous bone marrow mononuclear cells On day 10 post silicone expander implant operation, patient has 200ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and divided to two equal parts. One half of BM-MNCs will be transplanted intradermally and subcutaneously to the expanded flap immediately while the other half will be cryopreserved and stored by standard process. On day 24, cryopreserved cells, obtained after rapid thawing, will be transplanted intradermally and subcutaneously.	Procedure: Autologous bone marrow mononuclear cells Autologous bone marrow-derived mononuclear cells, after isolated with a Ficoll technique from 100ml 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 On day 10 and 24 post silicone expander implant operation, patient has intradermally and subcutaneously injection of saline.	Procedure: Placebo Patients will have bone marrow aspiration under local anesthesia on day 10. Intradermally and subcutaneously injection of saline within expanded flap will be performed on that day and on day 24.

Arms

Assigned Interventions

Experimental: Autologous bone marrow mononuclear cells

On day 10 post silicone expander implant operation, patient has 200ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and divided to two equal parts. One half of BM-MNCs will be transplanted intradermally and subcutaneously to the expanded flap immediately while the other half will be cryopreserved and stored by standard process. On day 24, cryopreserved cells, obtained after rapid thawing, will be transplanted intradermally and subcutaneously.

Procedure: Autologous bone marrow mononuclear cells

Autologous bone marrow-derived mononuclear cells, after isolated with a Ficoll technique from 100ml 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

On day 10 and 24 post silicone expander implant operation, patient has intradermally and subcutaneously injection of saline.

Procedure: Placebo

Patients will have bone marrow aspiration under local anesthesia on day 10. Intradermally and subcutaneously injection of saline within expanded flap will be performed on that day and on day 24.

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 requiring tissue expansion between the age of 18 and 50 years 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 on day 10 post silicone expander implant operation. Half of the purified bone marrow mononuclear cells will be transplanted intradermally and subcutaneously to expanded flap immediately while the other half will be cryopreserved by standard protocol and transplanted on day 24. On the other side, Patients from the control group will have saline injection on day 10 and 24 post silicone expander implant operation.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

With scar or soft tissue deficiencies requiring soft tissue expansion therapy;

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

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
Shanghai, Shanghai, China, 200011

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:	Qingfeng Li, M. D., Ph. D, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
ClinicalTrials.gov Identifier:	NCT01209611 History of Changes
Other Study ID Numbers:	30730092
Study First Received:	September 2, 2010
Last Updated:	September 24, 2010
Health Authority:	China: National Natural Science Foundation

ClinicalTrials.gov processed this record on May 19, 2013

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