Study of the Effectiveness of Autologous Bone Marrow-Derived Mesenchymal Stem Cells in Fibrin to Treat Chronic Wounds

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roger Williams Medical Center
ClinicalTrials.gov Identifier:
NCT01751282
First received: December 13, 2012
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine the effectiveness of Autologous Bone Marrow-Derived Mesenchymal Stem Cells (MSCs) in the treatment of non-healing wounds.


Condition Intervention Phase
Non Healing Wounds
Genetic: Stem Cell
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Controlled Study to Evaluate the Effectiveness of the Use of Bone Marrow-Derived Mesenchymal Stem Cells (MSCs) in Fibrin in the Treatment of Chronic Wounds

Further study details as provided by Roger Williams Medical Center:

Primary Outcome Measures:
  • Wound closure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall rate of wound healing reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard therapy and control saline spray
Conventional standard therapy and control saline spray
Genetic: Stem Cell
Sham Comparator: standard therapy and fibrin spray
Conventional standard therapy and fibrin spray
Genetic: Stem Cell
Experimental: Conventional standard therapy and MSCs
Conventional Standard Therapy and MSCs (autologous bone marrow-derived mesenchymal stem cells) in fibrin spray.
Genetic: Stem Cell

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

A subject must meet the following conditions in order to be included in this trial:

  • Male or female subjects 18 years of age or older with chronic wounds
  • Wound present for at least 3 months with no evidence of healing
  • Wound size must be less than or equal to 15 cm2 at randomization
  • Subjects must understand and give written informed consent
  • Subjects must agree to have biopsies performed as per protocol

Exclusion Criteria:

The presence of the following circumstances classifies a subject as unacceptable for inclusion in this trial:

  • Evidence of active infection at the wound site or around the ulcer
  • Requirement for the use of systemic corticosteroids or immuno- suppressive agents
  • The subject is pregnant or breast-feeding
  • The subject is known to be HIV positive
  • The subject is known to be Hepatitis B or C positive
  • Glycosylated hemoglobin A1C (HbA1C) is > 12%
  • Poor nutritional status (albumin < 2.0 g/dL)
  • The subject has a history of active, systemic malignancy
  • Clinical evidence of bone exposure within the wound bed
  • The subject has a history of noncompliance to medical regimens and is not considered reliable
  • The subject is unable to understand the study evaluations and provide a written informed consent
  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: NCT01751282

Locations
United States, Rhode Island
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
Roger Williams Medical Center
Investigators
Principal Investigator: Vincent Falanga, MD Roger Williams Medical Center
  More Information

No publications provided

Responsible Party: Roger Williams Medical Center
ClinicalTrials.gov Identifier: NCT01751282     History of Changes
Other Study ID Numbers: RO1AR06034201A1
Study First Received: December 13, 2012
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roger Williams Medical Center:
Stem Cells
chronic wounds
fibrin
Bone marrow-derived mesenchymal stem cells

ClinicalTrials.gov processed this record on September 30, 2014