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出境医 / 临床实验 / Autologous Human Schwann Cells in Peripheral Nerve Repair

Autologous Human Schwann Cells in Peripheral Nerve Repair

Study Description
Brief Summary:
The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.

Condition or disease Intervention/treatment Phase
Peripheral Nerve Injuries Biological: autologous human Schwann cells Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : September 1, 2029
Estimated Study Completion Date : September 1, 2029
Arms and Interventions
Arm Intervention/treatment
Experimental: Autologous human Schwann cells
All participants will receive autologous human Schwann cells harvested from their own sural nerve.
 Biological: autologous human Schwann cells
Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix
Outcome Measures
Primary Outcome Measures :
  1. Number of participants with reported adverse events (AEs) [ Time Frame: 12 months post-transplantation ]
    The number of participants with reported AEs will be evaluated to assess safety. Using CTCAE v4.0 grading scale, all AEs that are Grade 3 or higher with treating physician's attribution of probable or definite relation to intervention will be included.

  2. Number of participants with reported cell product culture test failure [ Time Frame: 12 months post-transplantation ]
    Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.

  3. Change in muscle strength scale grade of affected limb muscles [ Time Frame: from baseline to 12 months post-transplantation ]
    The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.

  4. Sensory recovery scale grade of affected dermatomes [ Time Frame: from baseline to 12 months post-transplantation ]
    Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.

  5. Change in pain scores [ Time Frame: from baseline to 12 months post-transplantation ]
    The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.

  6. Change in pain characteristics (location, intensity, and description) [ Time Frame: from baseline to 12 months post-transplantation ]
    Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.

  7. Number of participants with reported tumorigenesis or unexpected changes in nerve structure [ Time Frame: 2 years post-transplantation ]
    Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).


Secondary Outcome Measures :
  1. Change in muscle strength scale grade of affected limb muscles [ Time Frame: from baseline to 5 years ]
    The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.

  2. Sensory recovery scale grade of affected dermatomes [ Time Frame: from baseline to 5 years ]
    Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.

  3. Change in pain scores [ Time Frame: from baseline to 5 years post-transplantation ]
    The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.

  4. Change in pain characteristics (location, intensity, and description) [ Time Frame: from baseline to 5 months post-transplantation ]
    Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.

  5. Nerve-graft continuity [ Time Frame: 2 weeks post-transplantation ]
    Ultrasound will be used to assess nerve-graft continuity.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year;
  • Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;
  • Between the ages of 18 and 65 years at last birthday;

Exclusion Criteria:

  • Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety);
  • Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve);
  • Persons with severe peripheral nerve injury gap length > 10 cm in length;
  • Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
  • Pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation;
  • Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
  • History of active substance abuse;
  • Persons allergic to gentamicin;
  • Persons who test positive for HIV or Hepatitis B or C virus;
Contacts and Locations

Contacts
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Contact: Katie Gant, PhD 305-243-7108 mpinfo@med.miami.edu

Locations
Layout table for location information
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Katie Gant, PhD    305-243-7108    MPinfo@med.miami.edu   
Principal Investigator: Allan D Levi, MD, PhD         
Sponsors and Collaborators
W. Dalton Dietrich
The Miami Project to Cure Paralysis
Investigators
Layout table for investigator information
Principal Investigator: Allan Levi, MD, PhD University of Miami
Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date February 5, 2021
Actual Study Start Date  ICMJE September 24, 2019
Estimated Primary Completion Date September 1, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Number of participants with reported adverse events (AEs) [ Time Frame: 12 months post-transplantation ]
    The number of participants with reported AEs will be evaluated to assess safety. Using CTCAE v4.0 grading scale, all AEs that are Grade 3 or higher with treating physician's attribution of probable or definite relation to intervention will be included.
  • Number of participants with reported cell product culture test failure [ Time Frame: 12 months post-transplantation ]
    Using sterility testing, the number of participants with reported cell product culture test failure will be evaluated.
  • Change in muscle strength scale grade of affected limb muscles [ Time Frame: from baseline to 12 months post-transplantation ]
    The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.
  • Sensory recovery scale grade of affected dermatomes [ Time Frame: from baseline to 12 months post-transplantation ]
    Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
  • Change in pain scores [ Time Frame: from baseline to 12 months post-transplantation ]
    The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.
  • Change in pain characteristics (location, intensity, and description) [ Time Frame: from baseline to 12 months post-transplantation ]
    Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.
  • Number of participants with reported tumorigenesis or unexpected changes in nerve structure [ Time Frame: 2 years post-transplantation ]
    Tumorigenesis and/or unexpected changes in the nerve structure will be determined by evaluation of magnetic resonance imaging (MRI).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Change in muscle strength scale grade of affected limb muscles [ Time Frame: from baseline to 5 years ]
    The Medical Research Council (MRC) scale for muscle strength grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle.
  • Sensory recovery scale grade of affected dermatomes [ Time Frame: from baseline to 5 years ]
    Assessment of pin-prick and two point discrimination in areas previously anesthetic in the distal distribution of the nerve injury.
  • Change in pain scores [ Time Frame: from baseline to 5 years post-transplantation ]
    The Douleur Neuropathique 4 (DN4) questionnaire estimates the probability of neuropathic pain, based on 10 items. Seven items related to pain quality are based on an interview and 3 items are based on clinical examination.
  • Change in pain characteristics (location, intensity, and description) [ Time Frame: from baseline to 5 months post-transplantation ]
    Assessed by a pain diagram which identifies areas of pain with descriptors. An intensity scale from 0 (no pain) to 10 (most intense pain imaginable) is used to rate the overall intensity of pain at the time of assessment.
  • Nerve-graft continuity [ Time Frame: 2 weeks post-transplantation ]
    Ultrasound will be used to assess nerve-graft continuity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Human Schwann Cells in Peripheral Nerve Repair
Official Title  ICMJE The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
Brief Summary The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Peripheral Nerve Injuries
Intervention  ICMJE Biological: autologous human Schwann cells
Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix
Study Arms  ICMJE Experimental: Autologous human Schwann cells
All participants will receive autologous human Schwann cells harvested from their own sural nerve.
Intervention: Biological: autologous human Schwann cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2029
Estimated Primary Completion Date September 1, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year;
  • Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;
  • Between the ages of 18 and 65 years at last birthday;

Exclusion Criteria:

  • Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety);
  • Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve);
  • Persons with severe peripheral nerve injury gap length > 10 cm in length;
  • Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
  • Pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation;
  • Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
  • History of active substance abuse;
  • Persons allergic to gentamicin;
  • Persons who test positive for HIV or Hepatitis B or C virus;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katie Gant, PhD 305-243-7108 mpinfo@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03999424
Other Study ID Numbers  ICMJE 20190453
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party W. Dalton Dietrich, University of Miami
Study Sponsor  ICMJE W. Dalton Dietrich
Collaborators  ICMJE The Miami Project to Cure Paralysis
Investigators  ICMJE
Principal Investigator: Allan Levi, MD, PhD University of Miami
PRS Account University of Miami
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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