<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04487691</url>
  </required_header>
  <id_info>
    <org_study_id>RGX2020-RCT01</org_study_id>
    <nct_id>NCT04487691</nct_id>
  </id_info>
  <brief_title>Nebulized PL for Post-COVID-19 Syndrome</brief_title>
  <official_title>Autologous Nebulized Platelet Lysate for Post COVID-19 Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regenexx, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regenexx, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate and compare nebulized platelet lysate to placebo control of saline administered&#xD;
      via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in&#xD;
      patients with post-COVID-19 ARDS syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind, randomized, placebo controlled single-center study using nebulized&#xD;
      platelet lysate compared to placebo control of saline administered via handheld nebulizer 1x&#xD;
      daily for eight weeks to determine effect on lung function in patients with post-COVID-19&#xD;
      ARDS syndrome.&#xD;
&#xD;
      20 patients randomized to Treatment group: Inhaled nebulized platelet lysate (PL) 1x daily&#xD;
      for eight weeks 20 patients randomized to Control group: Inhaled nebulized saline, 1x daily&#xD;
      for eight weeks.&#xD;
&#xD;
      Outcomes will be measured at 4-weeks, 8-weeks, 3-months, 6- months&#xD;
&#xD;
      Goals for this study are as follows:&#xD;
&#xD;
        1. Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic&#xD;
           nebulizer, 2-ml once per day for 4-weeks compared to saline control (Phase 1), early&#xD;
           treatment timepoint.&#xD;
&#xD;
        2. Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic&#xD;
           nebulizer, 2-ml once per day for 8-weeks compared to saline control (Phase 1), final&#xD;
           treatment timepoint.&#xD;
&#xD;
        3. Investigate, compare, and monitor long term function and quality of life through&#xD;
           6-months for treatment arm compared to control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">December 8, 2020</start_date>
  <completion_date type="Actual">June 15, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Spirometry-FVC and FEV1/FVC tests</measure>
    <time_frame>4 weeks; 8 weeks</time_frame>
    <description>Changes in pre and post treatment spirometry measures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spirometry-FVC and FEV1/FVC tests</measure>
    <time_frame>3 months, 6 months</time_frame>
    <description>Changes from pre and post treatment spirometry measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minute Walk Distance test (6MWD)</measure>
    <time_frame>4 weeks; 8 weeks; 3 months; 6 months</time_frame>
    <description>Changes in distance walked during 6MWD test from pre to post treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance-desaturation product from 6MWD</measure>
    <time_frame>4 weeks; 8 weeks; 3 months; 6 months</time_frame>
    <description>Changes in distance-desaturation product from 6MWD from pre to post treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>San Diego Shortness of Breath Questionnaire (SOBQ)</measure>
    <time_frame>4 weeks; 8 weeks; 3 months; 6 months</time_frame>
    <description>Changes in San Diego Shortness of Breath Questionnaire (SOBQ) score from pre to post; treatment; scores range from 0-120 with higher scores equaling greater breathing impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 (SF-36)</measure>
    <time_frame>4 weeks; 8 weeks; 3 months; 6 months</time_frame>
    <description>Changes in SF-36 scores from pre to post treatment; 8 subscales 0-100 range where lower scores equal more disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Single Assessment Numeric Evaluation (SANE)</measure>
    <time_frame>4 weeks; 8 weeks; 3 months; 6 months</time_frame>
    <description>Average SANE score post treatment; scores range from 0-100 where 0=no improvement and 100=100% improvement in breathing condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medications</measure>
    <time_frame>4 weeks; 8 weeks; 3 months; 6 months</time_frame>
    <description>changes in medications from pre to post treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>4 weeks; 8 weeks; 3 months; 6 months</time_frame>
    <description>Incidence of adverse events after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of surgical/other treatment interventions</measure>
    <time_frame>4 weeks; 8 weeks; 3 months; 6 months</time_frame>
    <description>Incidence of surgical/other treatment interventions after treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Platelet Lysate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inhaled nebulized platelet lysate (PL), 2-ml 1x per day for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inhaled nebulized normal sterile saline, 2-ml 1x per day for 8-weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nebulized Platelet Lysate</intervention_name>
    <description>Approximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and platelet lysate (PL), maximizing the patients baseline platelet levels (~2-4x baseline) will be produced in a clean room setting using the Regenexx, LLC proprietary lab protocols (PL-M) utilizing a double lysis technique. From that sample, a high growth factor lysate will be created using a double lysis technique, and a sample will be retained to quantify the protein profile of the PL via ELISA quantitative analysis. The PL will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the platelet lysate following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks.</description>
    <arm_group_label>Platelet Lysate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nebulized Sterile Saline</intervention_name>
    <description>Approximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and donated for research purposes to keep patient blinded to group allocation. Sterile normal saline to mimic the appearance of the platelet lysate will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the sterile saline following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks.</description>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntary signature of the IRB approved Informed Consent&#xD;
&#xD;
          2. At least 4-weeks post ventilator or oxygen dependent ARDS treated for at least 48&#xD;
             hours in the ICU&#xD;
&#xD;
          3. Patient is stable enough to have been discharged home&#xD;
&#xD;
          4. Male or female ages 18-85&#xD;
&#xD;
          5. Two weeks to 1-year post hospital discharge&#xD;
&#xD;
          6. Ongoing activity intolerance due to dyspnea related to ARDS&#xD;
&#xD;
          7. Is independent, ambulatory, and can comply with all post-operative evaluations and&#xD;
             visits&#xD;
&#xD;
          8. 6-minute walk test distance of &lt; 450 M&#xD;
&#xD;
          9. SF-36 physical component score &lt; 60&#xD;
&#xD;
         10. ARDS caused by viral pneumonia including COVID-19 confirmed through an RNA anti-body&#xD;
             test&#xD;
&#xD;
         11. Normal to mild post-ARDS reactive airway disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Oxygen dependent on nasal canula greater than 2-L per minute&#xD;
&#xD;
          2. Dependent on inhaled corticosteroid at the discretion of the physician&#xD;
&#xD;
          3. Unable to complete any of the outcomes measured (Spirometry, 6MWD, SF-36, etc.)&#xD;
&#xD;
          4. Active known secondary bacterial or viral infection&#xD;
&#xD;
          5. Active moderate or severe post-ARDS reactive airway disease at the discretion of the&#xD;
             physician&#xD;
&#xD;
          6. Pre-morbid COPD&#xD;
&#xD;
          7. Medication list will be reviewed on a case by case basis to allow for flexibility as&#xD;
             post-COVID-19 patients' medication list may vary&#xD;
&#xD;
          8. Other medical comorbidities/conditions that may preclude participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Centeno, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centeno-Schultz Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centeno-Schultz Clinic</name>
      <address>
        <city>Broomfield</city>
        <state>Colorado</state>
        <zip>80021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Prem K, Liu Y, Russell TW, Kucharski AJ, Eggo RM, Davies N; Centre for the Mathematical Modelling of Infectious Diseases COVID-19 Working Group; Jit M, Klepac P. The effect of control strategies to reduce social mixing on outcomes of the COVID-19 epidemic in Wuhan, China: a modelling study. Lancet Public Health. 2020 May;5(5):e261-e270. doi: 10.1016/S2468-2667(20)30073-6. Epub 2020 Mar 25. Erratum In: Lancet Public Health. 2020 May;5(5):e260.</citation>
    <PMID>32220655</PMID>
  </reference>
  <reference>
    <citation>Chan KS, Pfoh ER, Denehy L, Elliott D, Holland AE, Dinglas VD, Needham DM. Construct validity and minimal important difference of 6-minute walk distance in survivors of acute respiratory failure. Chest. 2015 May;147(5):1316-1326. doi: 10.1378/chest.14-1808.</citation>
    <PMID>25742048</PMID>
  </reference>
  <reference>
    <citation>Hopkins RO, Weaver LK, Collingridge D, Parkinson RB, Chan KJ, Orme JF Jr. Two-year cognitive, emotional, and quality-of-life outcomes in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2005 Feb 15;171(4):340-7. doi: 10.1164/rccm.200406-763OC. Epub 2004 Nov 12.</citation>
    <PMID>15542793</PMID>
  </reference>
  <reference>
    <citation>Salama SM, Kamel IH, Ghanim M, Elsherif A. (2019). The Efficacy of Autologous Nebulized Platelet Rich Plasma (PRP) As an Early Adjuvant Therapeutic and Prognostic Treatment Modality in the Management of Inhalation Lung Injury. Egypt, J Plast Reconstr Surg. 43: 203-208. 10.21608/ejprs.2019.65115</citation>
  </reference>
  <reference>
    <citation>Geiger S, Hirsch D, Hermann FG. Cell therapy for lung disease. Eur Respir Rev. 2017 Jun 28;26(144):170044. doi: 10.1183/16000617.0044-2017. Print 2017 Jun 30.</citation>
    <PMID>28659506</PMID>
  </reference>
  <reference>
    <citation>Rubio MM. (2019). Beyond the Ordinary: The Effect of Cellular Therapy on Quality of Life in Chronic Lung Disease. J Clin Res Med. 2(4): 1-8. https://researchopenworld.com/beyond-the-ordinary-the-effect-of-cellular-therapy-on-quality-of-life-in-chronic-lung-disease/ Accessed 3/27/20.</citation>
  </reference>
  <reference>
    <citation>Mammoto T, Chen Z, Jiang A, Jiang E, Ingber DE, Mammoto A. Acceleration of Lung Regeneration by Platelet-Rich Plasma Extract through the Low-Density Lipoprotein Receptor-Related Protein 5-Tie2 Pathway. Am J Respir Cell Mol Biol. 2016 Jan;54(1):103-13. doi: 10.1165/rcmb.2015-0045OC.</citation>
    <PMID>26091161</PMID>
  </reference>
  <reference>
    <citation>Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.</citation>
    <PMID>29177632</PMID>
  </reference>
  <reference>
    <citation>Del Fante C, Perotti C, Bonferoni MC, Rossi S, Sandri G, Ferrari F, Scudeller L, Caramella CM. Platelet lysate mucohadesive formulation to treat oral mucositis in graft versus host disease patients: a new therapeutic approach. AAPS PharmSciTech. 2011 Sep;12(3):893-9. doi: 10.1208/s12249-011-9649-3. Epub 2011 Jul 6.</citation>
    <PMID>21732159</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>January 25, 2022</last_update_submitted>
  <last_update_submitted_qc>January 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04487691
org study id: RGX2020-RCT01
nct id: NCT04487691
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate and compare nebulized platelet lysate to placebo control of saline administered
      via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in
      patients with post-COVID-19 ARDS syndrome.
This is a double-blind, randomized, placebo controlled single-center study using nebulized
      platelet lysate compared to placebo control of saline administered via handheld nebulizer 1x
      daily for eight weeks to determine effect on lung function in patients with post-COVID-19
      ARDS syndrome.

      20 patients randomized to Treatment group: Inhaled nebulized platelet lysate (PL) 1x daily
      for eight weeks 20 patients randomized to Control group: Inhaled nebulized saline, 1x daily
      for eight weeks.

      Outcomes will be measured at 4-weeks, 8-weeks, 3-months, 6- months

      Goals for this study are as follows:

        1. Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic
           nebulizer, 2-ml once per day for 4-weeks compared to saline control (Phase 1), early
           treatment timepoint.

        2. Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic
           nebulizer, 2-ml once per day for 8-weeks compared to saline control (Phase 1), final
           treatment timepoint.

        3. Investigate, compare, and monitor long term function and quality of life through
           6-months for treatment arm compared to control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Spirometry-FVC and FEV1/FVC tests
time frame: 4 weeks; 8 weeks
description: Changes in pre and post treatment spirometry measures
measure: Spirometry-FVC and FEV1/FVC tests
time frame: 3 months, 6 months
description: Changes from pre and post treatment spirometry measures
measure: 6 Minute Walk Distance test (6MWD)
time frame: 4 weeks; 8 weeks; 3 months; 6 months
description: Changes in distance walked during 6MWD test from pre to post treatment
measure: Distance-desaturation product from 6MWD
time frame: 4 weeks; 8 weeks; 3 months; 6 months
description: Changes in distance-desaturation product from 6MWD from pre to post treatment
measure: San Diego Shortness of Breath Questionnaire (SOBQ)
time frame: 4 weeks; 8 weeks; 3 months; 6 months
description: Changes in San Diego Shortness of Breath Questionnaire (SOBQ) score from pre to post; treatment; scores range from 0-120 with higher scores equaling greater breathing impairment
measure: Short Form-36 (SF-36)
time frame: 4 weeks; 8 weeks; 3 months; 6 months
description: Changes in SF-36 scores from pre to post treatment; 8 subscales 0-100 range where lower scores equal more disability
measure: Modified Single Assessment Numeric Evaluation (SANE)
time frame: 4 weeks; 8 weeks; 3 months; 6 months
description: Average SANE score post treatment; scores range from 0-100 where 0=no improvement and 100=100% improvement in breathing condition
measure: Medications
time frame: 4 weeks; 8 weeks; 3 months; 6 months
description: changes in medications from pre to post treatment
measure: Incidence of adverse events
time frame: 4 weeks; 8 weeks; 3 months; 6 months
description: Incidence of adverse events after treatment
measure: Incidence of surgical/other treatment interventions
time frame: 4 weeks; 8 weeks; 3 months; 6 months
description: Incidence of surgical/other treatment interventions after treatment
arm group label: Platelet Lysate
arm group type: Experimental
description: Inhaled nebulized platelet lysate (PL), 2-ml 1x per day for 8 weeks.
arm group label: Saline
arm group type: Active Comparator
description: Inhaled nebulized normal sterile saline, 2-ml 1x per day for 8-weeks.
intervention type: Biological
intervention name: Nebulized Platelet Lysate
description: Approximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and platelet lysate (PL), maximizing the patients baseline platelet levels (~2-4x baseline) will be produced in a clean room setting using the Regenexx, LLC proprietary lab protocols (PL-M) utilizing a double lysis technique. From that sample, a high growth factor lysate will be created using a double lysis technique, and a sample will be retained to quantify the protein profile of the PL via ELISA quantitative analysis. The PL will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the platelet lysate following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks.
arm group label: Platelet Lysate
intervention type: Other
intervention name: Nebulized Sterile Saline
description: Approximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and donated for research purposes to keep patient blinded to group allocation. Sterile normal saline to mimic the appearance of the platelet lysate will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the sterile saline following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks.
arm group label: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Christopher Centeno, MD
role: Principal Investigator
affiliation: Centeno-Schultz Clinic
facility: 
country: United States
citation: Prem K, Liu Y, Russell TW, Kucharski AJ, Eggo RM, Davies N; Centre for the Mathematical Modelling of Infectious Diseases COVID-19 Working Group; Jit M, Klepac P. The effect of control strategies to reduce social mixing on outcomes of the COVID-19 epidemic in Wuhan, China: a modelling study. Lancet Public Health. 2020 May;5(5):e261-e270. doi: 10.1016/S2468-2667(20)30073-6. Epub 2020 Mar 25. Erratum In: Lancet Public Health. 2020 May;5(5):e260.
PMID: 32220655
citation: Chan KS, Pfoh ER, Denehy L, Elliott D, Holland AE, Dinglas VD, Needham DM. Construct validity and minimal important difference of 6-minute walk distance in survivors of acute respiratory failure. Chest. 2015 May;147(5):1316-1326. doi: 10.1378/chest.14-1808.
PMID: 25742048
citation: Hopkins RO, Weaver LK, Collingridge D, Parkinson RB, Chan KJ, Orme JF Jr. Two-year cognitive, emotional, and quality-of-life outcomes in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2005 Feb 15;171(4):340-7. doi: 10.1164/rccm.200406-763OC. Epub 2004 Nov 12.
PMID: 15542793
citation: Salama SM, Kamel IH, Ghanim M, Elsherif A. (2019). The Efficacy of Autologous Nebulized Platelet Rich Plasma (PRP) As an Early Adjuvant Therapeutic and Prognostic Treatment Modality in the Management of Inhalation Lung Injury. Egypt, J Plast Reconstr Surg. 43: 203-208. 10.21608/ejprs.2019.65115
citation: Geiger S, Hirsch D, Hermann FG. Cell therapy for lung disease. Eur Respir Rev. 2017 Jun 28;26(144):170044. doi: 10.1183/16000617.0044-2017. Print 2017 Jun 30.
PMID: 28659506
citation: Rubio MM. (2019). Beyond the Ordinary: The Effect of Cellular Therapy on Quality of Life in Chronic Lung Disease. J Clin Res Med. 2(4): 1-8. https://researchopenworld.com/beyond-the-ordinary-the-effect-of-cellular-therapy-on-quality-of-life-in-chronic-lung-disease/ Accessed 3/27/20.
citation: Mammoto T, Chen Z, Jiang A, Jiang E, Ingber DE, Mammoto A. Acceleration of Lung Regeneration by Platelet-Rich Plasma Extract through the Low-Density Lipoprotein Receptor-Related Protein 5-Tie2 Pathway. Am J Respir Cell Mol Biol. 2016 Jan;54(1):103-13. doi: 10.1165/rcmb.2015-0045OC.
PMID: 26091161
citation: Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.
PMID: 29177632
citation: Del Fante C, Perotti C, Bonferoni MC, Rossi S, Sandri G, Ferrari F, Scudeller L, Caramella CM. Platelet lysate mucohadesive formulation to treat oral mucositis in graft versus host disease patients: a new therapeutic approach. AAPS PharmSciTech. 2011 Sep;12(3):893-9. doi: 10.1208/s12249-011-9649-3. Epub 2011 Jul 6.
PMID: 21732159
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No