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Study to Evaluate Bone Marrow Cells in the Treatment of Chronic Wounds

NCT02319720 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-04-30

No results posted yet for this study

Summary

Management of chronic wounds with:

1. Bone Marrow Aspirate Plus Cultured Cells Group
2. Cultured Cells Alone Group
3. Bone Marrow Aspirate Alone Group
4. Control Group

Conditions

  • Ulcer

Interventions

BIOLOGICAL

Bone Marrow Aspirate

Fresh bone marrow aspirate administered to the wound at the time the bone marrow is taken.

BIOLOGICAL

Cultured Bone Marrow Cells

The bone marrow aspirate will be sent to the laboratory to be grown in tissue culture. Once the cell cultures have matured (within 8 weeks) they will be checked for sterility and frozen until applied to the subject's wound.

PROCEDURE

Control

The subjects in this group will receive currently approved treatments for their wound. These treatments will include debridement and dressing changes. Wound dressings allowed will include gauze, foam dressings, occlusive films, and non-stick pads. More advanced dressing materials such as Hydrocolloids, alginates, silver containing dressings, and biomaterials can also be used. Compression will be utilized for lower extremity wounds.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Aging (NIA)

    collaborator NIH

  • Dr. E.Badiavas

    lead OTHER

Principal Investigators

  • Evangelos V Badiavas, MD, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2013-03-31
Completion
2014-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02319720 on ClinicalTrials.gov