Peripheral Nerve Injury Upper LimbNCT03964129

BMAC Nerve Allograft Study

A study testing Avance Nerve Graft with Autologous BMAC in people with Peripheral Nerve Injury Upper Limb, run by Brooke Army Medical Center at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Peripheral Nerve Injury Upper Limb
What is being tested?: Avance Nerve Graft with Autologous BMAC
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 3 sitesUnited States
Study dates: 22 Aug 2017to 1 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 10Show fewer

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Curtis National Hand Center at MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234

Other trials in United States

About this study

Official title: Clinical Evaluation of Decellularized Nerve Allograft With Autologous Bone Marrow Aspirate Concentrate (BMAC) to Improve Peripheral Nerve Repair and Functional Outcomes

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
Being tested: Avance Nerve Graft with Autologous BMAC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Avance Nerve Graft with Autologous BMACProcedure or surgery
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.

Study groups in NCT03964129
Study group	Role	What they receive
Avance Nerve Graft with autologous BMAC	Experimental	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. Receives: Procedure: Avance Nerve Graft with Autologous BMAC

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 18 months

Secondary outcomes (2)

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.
Measured: 18 months
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%
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 20171 Jun 2021

First posted28 May 2019
Study start22 Aug 2017
Primary completion30 Nov 2020 (estimated)
Study completion1 Jun 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (48)Papers the sponsor has linked to this study.
Other trials for Peripheral Nerve Injury Upper LimbStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03964129
Sponsor's protocol ID: C.2017.074
Status last verified: Jul 2020
First submitted: 20 May 2019
Last updated: 16 Jul 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Brooks DN, Weber RV, Chao JD, Rinker BD, Zoldos J, Robichaux MR, Ruggeri SB, Anderson KA, Bonatz EE, Wisotsky SM, Cho MS, Wilson C, Cooper EO, Ingari JV, Safa B, Parrett BM, Buncke GM. Processed nerve allografts for peripheral nerve reconstruction: a multicenter study of utilization and outcomes in sensory, mixed, and motor nerve reconstructions. Microsurgery. 2012 Jan;32(1):1-14. doi: 10.1002/micr.20975. Epub 2011 Nov 28.
PubMed 22121093
Berger A, Millesi H. Nerve grafting. Clin Orthop Relat Res. 1978 Jun;(133):49-55.
PubMed 688717
Brushart, T.M. (2011). Nerve Repair (Oxford University Press).
Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30.
PubMed 27026621
Center for Biologics Evaluation and Research, C. for D. and R.H. Cellular & Gene Therapy Guidances - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance.
Chen CJ, Ou YC, Liao SL, Chen WY, Chen SY, Wu CW, Wang CC, Wang WY, Huang YS, Hsu SH. Transplantation of bone marrow stromal cells for peripheral nerve repair. Exp Neurol. 2007 Mar;204(1):443-53. doi: 10.1016/j.expneurol.2006.12.004. Epub 2007 Jan 12.
PubMed 17222827
Cho MS, Rinker BD, Weber RV, Chao JD, Ingari JV, Brooks D, Buncke GM. Functional outcome following nerve repair in the upper extremity using processed nerve allograft. J Hand Surg Am. 2012 Nov;37(11):2340-9. doi: 10.1016/j.jhsa.2012.08.028.
PubMed 23101532
Dezawa M, Takahashi I, Esaki M, Takano M, Sawada H. Sciatic nerve regeneration in rats induced by transplantation of in vitro differentiated bone-marrow stromal cells. Eur J Neurosci. 2001 Dec;14(11):1771-6. doi: 10.1046/j.0953-816x.2001.01814.x.
PubMed 11860471
Ding F, Wu J, Yang Y, Hu W, Zhu Q, Tang X, Liu J, Gu X. Use of tissue-engineered nerve grafts consisting of a chitosan/poly(lactic-co-glycolic acid)-based scaffold included with bone marrow mesenchymal cells for bridging 50-mm dog sciatic nerve gaps. Tissue Eng Part A. 2010 Dec;16(12):3779-90. doi: 10.1089/ten.TEA.2010.0299. Epub 2010 Sep 6.
PubMed 20666610
Ducic I, Fu R, Iorio ML. Innovative treatment of peripheral nerve injuries: combined reconstructive concepts. Ann Plast Surg. 2012 Feb;68(2):180-7. doi: 10.1097/SAP.0b013e3182361b23.
PubMed 22270569
Dvali L, Mackinnon S. Nerve repair, grafting, and nerve transfers. Clin Plast Surg. 2003 Apr;30(2):203-21. doi: 10.1016/s0094-1298(02)00096-2.
PubMed 12737353
Frykman, G., and Gramyk, K. (1991). Results of Nerve Grafting In: Gelberman R. Operative nerve repair and reconstruction. (JB Lippincott).
Galanakos SP, Zoubos AB, Ignatiadis I, Papakostas I, Gerostathopoulos NE, Soucacos PN. Repair of complete nerve lacerations at the forearm: an outcome study using Rosen-Lundborg protocol. Microsurgery. 2011 May;31(4):253-62. doi: 10.1002/micr.20845. Epub 2010 Dec 3.
PubMed 21557303
Graham, James B., Xue, Qing-Shan, Neubauer, Debbie, and Muir, David (2009). A chondroitinase-treated, decellularized nerve allograft compares favorably to the cellular isograft in rat peripheral nerve repair. 2, 19-29
Guo Y, Chen G, Tian G, Tapia C. Sensory recovery following decellularized nerve allograft transplantation for digital nerve repair. J Plast Surg Hand Surg. 2013 Dec;47(6):451-3. doi: 10.3109/2000656X.2013.778862. Epub 2013 Jul 15.
PubMed 23848418

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Comparison of Kinesio Taping Techniques in Ulnar Nerve Entrapment
Ulnar Nerve Entrapment, Cubital Tunnel Syndrome
RecruitingPhase 4
Study Comparing Avance Nerve Graft and Autograft for Functional Recovery Following Mixed and Motor Peripheral Nerve Reconstruction
Peripheral Nerve Injury, Peripheral Nerve Discontinuity
RecruitingPhase 3
This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
Peripheral Nerve Injury Upper Limb, Peripheral Nerve Injury (PNI)
Recruiting
Effects of Peripheral Repetitive Peripheral Magnetic Stimulation on Individuals With Elbow or Wrist Chronic Pain
Tennis Elbow Syndrome, Golfer's Elbow
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)

All Peripheral Nerve Injury Upper Limb trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Decellularized Nerve Allograft With Autologous Bone Marrow Aspirate Concentrate (BMAC) to Improve Peripheral Nerve Repair and Functional Outcomes
ClinicalTrials.gov ID: NCT03964129
Acronym / sponsor ID: C.2017.074
Conditions: Peripheral Nerve Injury Upper Limb
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 15 participants (actual)
Lead sponsor: Brooke Army Medical CenterUS federal agency
Collaborators: Walter Reed National Military Medical Center, Curtis National Hand Center at MedStar Union Memorial Hospital, Cleveland Clinic Lerner Research Institute
Study start: 22 Aug 2017 (actual)
Primary completion: 30 Nov 2020 (estimated)
Study completion: 1 Jun 2021 (estimated)
First posted: 28 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Avance Nerve Graft with autologous BMAC	Experimental	Procedure: Avance Nerve Graft with Autologous BMACThe 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.

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Avance Nerve Graft with Autologous BMACThe 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.	Procedure or surgery	Avance Nerve Graft with autologous BMAC

Primary outcome

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.
Time frame: 18 months
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.

2 secondary outcomes

Test of non-inferiority and superiority of Avance Nerve Graft to historical nerve autograft scores with respect to Rosen-Lundborg using closed testing procedures
Time frame: 18 months
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
Time frame: 18 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
Background: PubMed 22121093Brooks DN, Weber RV, Chao JD, Rinker BD, Zoldos J, Robichaux MR, Ruggeri SB, Anderson KA, Bonatz EE, Wisotsky SM, Cho MS, Wilson C, Cooper EO, Ingari JV, Safa B, Parrett BM, Buncke GM. Processed nerve allografts for peripheral nerve reconstruction: a multicenter study of utilization and outcomes in sensory, mixed, and motor nerve reconstructions. Microsurgery. 2012 Jan;32(1):1-14. doi: 10.1002/micr.20975. Epub 2011 Nov 28.
Background: PubMed 688717Berger A, Millesi H. Nerve grafting. Clin Orthop Relat Res. 1978 Jun;(133):49-55.
BackgroundBrushart, T.M. (2011). Nerve Repair (Oxford University Press).
Background: PubMed 27026621Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30.
BackgroundCenter for Biologics Evaluation and Research, C. for D. and R.H. Cellular & Gene Therapy Guidances - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance.
Background: PubMed 17222827Chen CJ, Ou YC, Liao SL, Chen WY, Chen SY, Wu CW, Wang CC, Wang WY, Huang YS, Hsu SH. Transplantation of bone marrow stromal cells for peripheral nerve repair. Exp Neurol. 2007 Mar;204(1):443-53. doi: 10.1016/j.expneurol.2006.12.004. Epub 2007 Jan 12.
Background: PubMed 23101532Cho MS, Rinker BD, Weber RV, Chao JD, Ingari JV, Brooks D, Buncke GM. Functional outcome following nerve repair in the upper extremity using processed nerve allograft. J Hand Surg Am. 2012 Nov;37(11):2340-9. doi: 10.1016/j.jhsa.2012.08.028.
Background: PubMed 11860471Dezawa M, Takahashi I, Esaki M, Takano M, Sawada H. Sciatic nerve regeneration in rats induced by transplantation of in vitro differentiated bone-marrow stromal cells. Eur J Neurosci. 2001 Dec;14(11):1771-6. doi: 10.1046/j.0953-816x.2001.01814.x.
Background: PubMed 20666610Ding F, Wu J, Yang Y, Hu W, Zhu Q, Tang X, Liu J, Gu X. Use of tissue-engineered nerve grafts consisting of a chitosan/poly(lactic-co-glycolic acid)-based scaffold included with bone marrow mesenchymal cells for bridging 50-mm dog sciatic nerve gaps. Tissue Eng Part A. 2010 Dec;16(12):3779-90. doi: 10.1089/ten.TEA.2010.0299. Epub 2010 Sep 6.
Background: PubMed 22270569Ducic I, Fu R, Iorio ML. Innovative treatment of peripheral nerve injuries: combined reconstructive concepts. Ann Plast Surg. 2012 Feb;68(2):180-7. doi: 10.1097/SAP.0b013e3182361b23.
Background: PubMed 12737353Dvali L, Mackinnon S. Nerve repair, grafting, and nerve transfers. Clin Plast Surg. 2003 Apr;30(2):203-21. doi: 10.1016/s0094-1298(02)00096-2.
BackgroundFrykman, G., and Gramyk, K. (1991). Results of Nerve Grafting In: Gelberman R. Operative nerve repair and reconstruction. (JB Lippincott).

Related trials for Peripheral Nerve Injury Upper Limb

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Comparison of Kinesio Taping Techniques in Ulnar Nerve Entrapment
Ulnar Nerve Entrapment, Cubital Tunnel Syndrome
RecruitingPhase 4
Study Comparing Avance Nerve Graft and Autograft for Functional Recovery Following Mixed and Motor Peripheral Nerve Reconstruction
Peripheral Nerve Injury, Peripheral Nerve Discontinuity
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This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julia Nuelle, MD principal investigator

Brooke Army Medical Center

Leon J Nesti, MD/PhD principal investigator

Walter Reed National Military Medical Center

Kenneth Means, MD principal investigator

Curtis Hand Center at MedStar Union Memorial Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Avance Nerve Graft with Autologous BMAC in people with Peripheral Nerve Injury Upper Limb, run by Brooke Army Medical Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03964129, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.