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BMAC Nerve Allograft Study

NCT03964129 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-07-16

No results posted yet for this study

Summary

This study is a prospective, multi-center, proof of principle, phase I human safety study evaluating the sequential treatments of the Avance Nerve Graft, a commercially available decellularized processed peripheral nerve allograft, with autologous Bone Marrow Aspirate Concentrate (BMAC), a source of stem cells, for the repair of peripheral nerve injuries up to 7 cm in length. The purpose of this study is to establish a knowledge product, evaluating the safety profile of the Avance Nerve Graft, followed by the application of BMAC to support further investment into the promising area of using stem cells in conjunction with scaffolds.

Conditions

  • Peripheral Nerve Injury Upper Limb

Interventions

PROCEDURE

Avance Nerve Graft with Autologous BMAC

The Avance Nerve Graft will be inserted in the area of nerve injury. Between 40 to 60 ml of Bone Marrow Aspirate from the anterior or posterior iliac crest of the pelvis will be harvested. Using SmartPrep centrifuge and 60 ml BMAC kit, 7 to 10 ml of final BMAC will be obtained. Of the 7 to 10 ml of final BMAC that is yielded, half (3.5 to 5 ml) of the final concentrate, will be injected on top of the Avance Nerve Graft following coaptation. The second half (3.5 to 5 ml) of the final concentrate will be inserted into a sterile tube containing culture media and shipped overnight to Cleveland Clinic Lerner Research Institute for cell processing and colony assay to confirm that the BMAC indeed contains autologous bone marrow stem cells.

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    collaborator FED

  • Curtis National Hand Center at MedStar Union Memorial Hospital

    collaborator UNKNOWN

  • Cleveland Clinic Lerner Research Institute

    collaborator UNKNOWN

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Julia Nuelle, MD · Brooke Army Medical Center

  • Leon J Nesti, MD/PhD · Walter Reed National Military Medical Center

  • Kenneth Means, MD · Curtis Hand Center at MedStar Union Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2020-11-30
Completion
2021-06-01

Countries

  • United States

Study Locations

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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 NCT03964129 on ClinicalTrials.gov