Back to resultsBMAC Nerve Allograft Study
Primary Purpose
Peripheral Nerve Injury Upper Limb
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avance Nerve Graft with Autologous BMAC
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Nerve Injury Upper Limb
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant female 18 to 74 years of age.
- Undergoing peripheral nerve exploration or grafting with allograft in the upper extremity.
- Subjects must be inpatients or scheduled for surgery at the time of study enrollment.
- Has nerve conduction block injuries to the ulnar, median, radial or musculocutaneous nerve of either upper extremities that is less than two years from injury.
- Be willing to undergo tension free end-to-end nerve graft coaptation on both the proximal and distal portion of the nerve gap with the Avance Nerve Graft.
- Be willing to have bone marrow harvested from own body, concentrated, and applied to the site of nerve injury following the insertion of the Avance Nerve Graft.
- Be willing to participate and able to comply with all aspects of the treatment and evaluation schedule over a 18-month duration.
- Capable of giving their own consent to participate in the study, and willing to sign and date an IRB-approved written informed consent prior to initiation of any study procedures.
- Nerve conduction injury affecting sensory and motor function or solely motor function in the upper extremity.
- Nerve gaps following resection, up to 7 cm, inclusive.
Exclusion Criteria:
- Subjects with Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus requiring regular insulin therapy.
- Subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system.
- History of neurodegenerative disease, neuropathy, or diabetic neuropathy.
- History of chronic ischemic condition of the upper extremity.
- Cognitive limitation or mental illness preventing informed consent.
- Nerve injuries >2 years post initial injury.
- Any participant who at the discretion of the Investigator is not suitable for inclusion in the study.
Sites / Locations
- Curtis National Hand Center at MedStar Union Memorial Hospital
- Walter Reed National Military Medical Center
- San Antonio Military Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Avance Nerve Graft with autologous BMAC
Arm Description
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.
Outcomes
Primary Outcome Measures
Comparison of the nature and incidence of AEs between the group of subjects receiving Avance Nerve Graft with BMAC and the historical data of nerve repairs with the Avance Nerve Graft.
Long-term study associated AEs, such as infection, wound dehiscence, neuropathy, carpal tunnel syndrome, bleeding, seroma, and lymphocele will be captured and analyzed together with any change in incidence of listed AEs which may be precipitated by treatment. . AEs will be mapped to a MedDRA preferred term and system organ classification. The occurrence of the AEs will be summarized by repair type using MedDRA preferred terms, system organ classifications, and severity. All AEs will be listed for individual subjects showing both verbatim and preferred terms. Separate summaries of treatment-emergent SAEs and AEs related to repair will be generated.
Secondary Outcome Measures
Test of non-inferiority and superiority of Avance Nerve Graft to historical nerve autograft scores with respect to Rosen-Lundborg using closed testing procedures
Test of non-inferiority and superiority of Avance Nerve Graft to historical nerve autograft scores with respect to Rosen-Lundborg will be conducted using closed testing procedures. The hypotheses being tested are as follows:
H01: Δ ≤ -Δ0 vs. H11: Δ > -Δ0 H02: Δ = 0 vs. H12: Δ ≠ 0 where Δ = μC- μA is the difference between the mean Rosen-Lundborg Scores for the Avance Nerve Graft & BMAC (μA) and the mean Rosen-Lundborg scores for the historical autograft controls (μC), Δ0 is the non-inferiority margin 0.51. The null hypothesis of non-inferiority (H01) will be tested first and, if rejected, then the null hypothesis of superiority (H02) will be assessed. Given that the closed testing procedure is implemented, no adjustment for multiple testing will be required.
Test of non-inferiority of Avance Nerve Graft plus BMAC to Avance Nerve Graft recovery rates with respect to Rosen-Lundborg scores using closed testing procedures
Test of non-inferiority of Avance Nerve Graft plus BMAC to Avance Nerve Graft recovery rates with respect to Rosen-Lundborg scores will be conducted using closed testing procedures. The hypothesis being tested is as follows:
H01: πA - πAB > Δ vs. H11: πA - πAB < Δ where πA is the recovery of Avance Nerve Graft and πAB is the recovery of Avance plus BMAC. Δ is the non-inferiority margin 25%
Full Information
NCT ID
NCT03964129
First Posted
May 20, 2019
Last Updated
July 15, 2020
Sponsor
Brooke Army Medical Center
Collaborators
Walter Reed National Military Medical Center, Curtis National Hand Center at MedStar Union Memorial Hospital, Cleveland Clinic Lerner Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03964129
Brief Title
BMAC Nerve Allograft Study
Official Title
Clinical Evaluation of Decellularized Nerve Allograft With Autologous Bone Marrow Aspirate Concentrate (BMAC) to Improve Peripheral Nerve Repair and Functional Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center
Collaborators
Walter Reed National Military Medical Center, Curtis National Hand Center at MedStar Union Memorial Hospital, Cleveland Clinic Lerner Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nerve Injury Upper Limb
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avance Nerve Graft with autologous BMAC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Avance Nerve Graft with Autologous BMAC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of the nature and incidence of AEs between the group of subjects receiving Avance Nerve Graft with BMAC and the historical data of nerve repairs with the Avance Nerve Graft.
Description
Long-term study associated AEs, such as infection, wound dehiscence, neuropathy, carpal tunnel syndrome, bleeding, seroma, and lymphocele will be captured and analyzed together with any change in incidence of listed AEs which may be precipitated by treatment. . AEs will be mapped to a MedDRA preferred term and system organ classification. The occurrence of the AEs will be summarized by repair type using MedDRA preferred terms, system organ classifications, and severity. All AEs will be listed for individual subjects showing both verbatim and preferred terms. Separate summaries of treatment-emergent SAEs and AEs related to repair will be generated.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Test of non-inferiority and superiority of Avance Nerve Graft to historical nerve autograft scores with respect to Rosen-Lundborg using closed testing procedures
Description
Test of non-inferiority and superiority of Avance Nerve Graft to historical nerve autograft scores with respect to Rosen-Lundborg will be conducted using closed testing procedures. The hypotheses being tested are as follows:
H01: Δ ≤ -Δ0 vs. H11: Δ > -Δ0 H02: Δ = 0 vs. H12: Δ ≠ 0 where Δ = μC- μA is the difference between the mean Rosen-Lundborg Scores for the Avance Nerve Graft & BMAC (μA) and the mean Rosen-Lundborg scores for the historical autograft controls (μC), Δ0 is the non-inferiority margin 0.51. The null hypothesis of non-inferiority (H01) will be tested first and, if rejected, then the null hypothesis of superiority (H02) will be assessed. Given that the closed testing procedure is implemented, no adjustment for multiple testing will be required.
Time Frame
18 months
Title
Test of non-inferiority of Avance Nerve Graft plus BMAC to Avance Nerve Graft recovery rates with respect to Rosen-Lundborg scores using closed testing procedures
Description
Test of non-inferiority of Avance Nerve Graft plus BMAC to Avance Nerve Graft recovery rates with respect to Rosen-Lundborg scores will be conducted using closed testing procedures. The hypothesis being tested is as follows:
H01: πA - πAB > Δ vs. H11: πA - πAB < Δ where πA is the recovery of Avance Nerve Graft and πAB is the recovery of Avance plus BMAC. Δ is the non-inferiority margin 25%
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Comparison of Motor Percent Recovery to Baseline Range of Motion
Description
Percent of motor recovery to baseline (defined as the difference in the measured assessment of the repaired nerve as compared with neighboring uninjured and/or contra-lateral side) based on passive range of motion, active range of motion and muscle strength (M0-M5) measurements
Time Frame
18 months
Title
Comparison of Motor Percent Recovery to Baseline Grip Strength
Description
Percent of grip strength recovery to baseline (defined as the difference in the measured assessment of the repaired nerve as compared with neighboring uninjured and/or contra-lateral side) measured in kilograms using the Neurosensory & Motor Testing System AcroGrip Device
Time Frame
18 months
Title
Comparison of Motor Percent Recovery to Baseline Pinch Strength
Description
Percent of pinch strength recovery to baseline (defined as the difference in the measured assessment of the repaired nerve as compared with neighboring uninjured and/or contra-lateral side) measured in kilograms using the Neurosensory & Motor Testing System AcroPinch Device
Time Frame
18 months
Title
Time to Recovery
Time Frame
18 months
Title
Functional Outcomes through the assessment of Quick Disabilities of the Arm Shoulder and Hand (QuickDASH) questionnaire
Description
QuickDASH Disability/Symptom, Work Module, and Sports/Performing Arts Module Raw Score (out of 5) and Final Score (out of 100) will be recorded. Raw Scores will be calculated by: Raw Score = sum of n responses/n, where n is equal to number of completed items.The Final Score (out of 100) scaled from 0 indicating least disability to 100 indicating most disability will be calculated by: Final score = (Raw Score - 1) X 25
Time Frame
18 months
Title
Functional Outcomes through the assessment of Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
Raw and Standardized scores for Physical Function, Pain Intensity, Pain Interference, Fatigue, Sleep Disturbance and Behavior assessments will be recorded. Raw Scores will be calculated by: (Raw Sum X number of items listed in the domain)/Number of items that were actually answered for each assessment. The Raw Score is then systematically transformed to a standardized T-score using a conversion table in the PROMIS Scoring Manual. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. The higher the T-score, the more it represents the concept being measured
Time Frame
18 months
Title
Motor and Sensory Nerve Conduction Studies (Nerve Conduction Velocity (NCV) and/or Electromyography (EMG))
Description
NCV and EMG testing will be conducted on the target muscle group to assess rate and level of motor and sensory reinnervation in the 12 month and 18 month
Rate of Reinnervation (Motor and Sensory Domain)
Level of Reinnervation (Motor and Sensory Domain)
Time Frame
12 and 18 month
Title
Comparison of Sensory Percent Recovery to Baseline
Description
Percent of sensory recovery to baseline (defined as the difference in the measured assessment of the repaired nerve as compared with neighboring uninjured and/or contra-lateral side) using the Neurosensory & Motor Testing System (NSMTS) Pressure Specified Sensory Device. 1 Point Static Discrimination, 1 Point Static Moving Discrimination, 2 Point Static Discrimination and 2 Point Moving Discrimination will be measured by prong pressure (g/mm^2)
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant female 18 to 74 years of age.
Undergoing peripheral nerve exploration or grafting with allograft in the upper extremity.
Subjects must be inpatients or scheduled for surgery at the time of study enrollment.
Has nerve conduction block injuries to the ulnar, median, radial or musculocutaneous nerve of either upper extremities that is less than two years from injury.
Be willing to undergo tension free end-to-end nerve graft coaptation on both the proximal and distal portion of the nerve gap with the Avance Nerve Graft.
Be willing to have bone marrow harvested from own body, concentrated, and applied to the site of nerve injury following the insertion of the Avance Nerve Graft.
Be willing to participate and able to comply with all aspects of the treatment and evaluation schedule over a 18-month duration.
Capable of giving their own consent to participate in the study, and willing to sign and date an IRB-approved written informed consent prior to initiation of any study procedures.
Nerve conduction injury affecting sensory and motor function or solely motor function in the upper extremity.
Nerve gaps following resection, up to 7 cm, inclusive.
Exclusion Criteria:
Subjects with Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus requiring regular insulin therapy.
Subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system.
History of neurodegenerative disease, neuropathy, or diabetic neuropathy.
History of chronic ischemic condition of the upper extremity.
Cognitive limitation or mental illness preventing informed consent.
Nerve injuries >2 years post initial injury.
Any participant who at the discretion of the Investigator is not suitable for inclusion in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Nuelle, MD
Organizational Affiliation
Brooke Army Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leon J Nesti, MD/PhD
Organizational Affiliation
Walter Reed National Military Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Means, MD
Organizational Affiliation
Curtis Hand Center at MedStar Union Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Curtis National Hand Center at MedStar Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
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BMAC Nerve Allograft Study
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