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Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Biological/Vaccine: Allogeneic HB-adMSCs
Placebo
Sponsored by
Hope Biosciences Stem Cell Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A study participant will be eligible for inclusion in this study only if all the following criteria apply:

    1. Male and female participants 45 - 80 years of age.
    2. At the screening visit, study participants must have an MDS-UPDRS part II score between 7 and 28.
    3. Study participants must have an MDS-UPDRS part III score between 20 and 57 during the screening visit.
    4. Carbidopa/Levodopa total dosage must be less than 1200 mg per day for study participants.
    5. The total Levodopa equivalent dose for study participants must be less than 1400 mg per day.
    6. Study participant must have been diagnosed with early and/or moderate Parkinson's disease at least 2 years prior study participation.
    7. Study participants should be able to read, understand and to provide written consent.
    8. Voluntarily signed informed consent obtained before any clinical-trial related procedures are performed.
    9. Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration.
    10. Male participants if their sexual partners can become pregnant should use a method of contraception during study participation and for 6 months after the last administration of the investigated product.
    11. Study participant is able and willing to comply with the requirements of this clinical trial.

Exclusion Criteria:

  • A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply:

    1. Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures.
    2. Study participants with advanced Parkinson's disease described as, severe disability, wheelchair bound or bedridden.
    3. Study participant has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
    4. Study participant has known alcoholic addiction or dependency or has current substance use or abuse.
    5. Study participant has 1 or more significant concurrent medical conditions (verified by medical records), including the following:

      • Poorly controlled diabetes mellitus (PCDM) defined as history of deficient standard of care treatment and/or pre-prandial glucose >130mg/dl during screening visit or post-prandial glucose >200mg/dl.
      • Medical History of Chronic kidney disease (CKD) diagnosis and/or screening results of eGFR < 59mL/min/1.73m2.
      • Presence of New York Heart Association (NYHA) Class III/IV heart failure during screening visit.
      • Any medical history of myocardial infarction in any of the different types, such as ST-elevation myocardial infarction (STEMI) or non-ST-elevated myocardial infarction (NSTEMI), coronary spasm, or unstable angina.
      • Medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure > 180/120 mm/Hg during screening visit.
      • Medical history of inherited thrombophilias, recent major general surgery, (within 12 months before the Screening), lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips or femur, cancer of the lung, brain, lymphatic, gynecologic system (ovary or uterus), or gastrointestinal tract (like pancreas or stomach).
      • History of brain surgery for Parkinson's disease.
    6. Study participant has received any stem cell treatment within 6 months before first dose of investigational product other than stem cells produced by Hope Biosciences.
    7. Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.
    8. Study participant has a laboratory abnormality during screening, including the following:

      • White blood cell count < 3000/mm3
      • Platelet count < 80,000mm3
      • Absolute neutrophil count < 1500/mm3
      • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 10 upper limit of normal (ULN) x 1.5
    9. Study participant has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study.
    10. Study participant is unlikely to complete the study or adhere to the study procedures.
    11. Study participant with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.
    12. Study participant has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments.
    13. Study participant with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
    14. Male study participants who plan to donate sperm during the study or within 6 months after the last dose. Female patients who plan to donate eggs or undergo in vitro fertilization treatment during the study or within 6 months after the last dose.

Sites / Locations

  • Hope Biosciences Stem Cell Research FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allogeneic HB-adMSCs.

Placebo

Arm Description

Biological/Vaccine: Allogeneic HB-adMSCs Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify. Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.

Placebo will be administered intravenously to study participants who qualify. Other Names: Sterile Saline Solution 0.9%

Outcomes

Primary Outcome Measures

1. Changes in the total score MDS-UPDRS Part II.
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II.
2. Incidence of treatment-emergent Adverse Event (TEAEs).
Treatment-emergent Adverse Event.
3. Incidence of treatment-emergent Serious Adverse Events (SAEs).
SSAEs.
4. AEs of special interest (serious or non-serious) - thromboembolic events.
Incidence of thromboembolic events.
5. AEs of special interest (serious or non-serious) - thromboembolism of the extremities
Incidence and risk of AEs of special interest (serious or non-serious), including peripheral events defined as, thromboembolism of the extremities.
6. AEs of special interest (serious or non-serious) - infections
Incidence and risk of AEs of special interest (serious or non-serious), including infections.
7. AEs of special interest (serious or non-serious) - hypersensitivities.
Incidence and risk of AEs of special interest (serious or non-serious), including hypersensitivities.
8. Laboratory value Complete Blood Count (CBC)
Clinically significant changes in CBC values.
9. Laboratory values Chemistry Metabolic Panel (CMP)
Number of Participants with changes in Laboratory CMP values
10. Laboratory values Coagulation Panel; Prothrombin time, Partial Prothrombin time, and INtern
Number of Participants with changes in Laboratory Coagulation Panel values.
11. Vital signs. - Respiratory Rate (breaths per minute)
Number of Participants with Clinically significant changes in Respiratory Rate.
12. Vital signs. - Heart Rate (beats per minute)
Number of Participants with Clinically significant changes in Heart Rate.
13. Vital signs. - Body Temperature (Fahrenheit )
Number of participants with Clinically significant changes in Heart Rate.
14. Vital signs. - Blood Pressure (mmHg)
Number of Participants with Clinically significant changes in Blood Pressure.
15. Weight in lb.
Number of Participants with Clinically significant changes in Weight in lb.
16. Physical examination results. General
Number of Participants with Clinically significant changes in general physical examination results.
17. Physical examination results. Body Systems.
Number of Participants with Clinically significant changes in body systems physical examination results.

Secondary Outcome Measures

18. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale -UPDRS Part I.
Changes in MDS-UPDRS Part I
19. Changes in the total score Movement Disorder Society Unified Parkinson's Disease Rating Scale -UPDRS Part II and Part III.
Changes in Total score MDS-UPDRS Part II and Part III
20. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part III.
Changes in MDS-UPDRS Part III
21. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part IV.
Changes in MDS-UPDRS Part IV
22. Changes in Short Form 36 Health Survey Questionnaire (SF-36).
Changes in SF-36
23. Changes in Parkinson's disease fatigue scale (PFS-16)
Improvements in Participants PFS-16 scores
24. Changes in Parkinson's disease Questionnaire (PDQ-39).
Improvements in Participants PDQ-39 scores
25. Changes in Visual Analog Scale for Pain.
Changes in Participants VAS Pain Scales
26. Changes in Visual Analog Scale for Muscle spasms.
Changes in Participants VAS spasms Scale
27. Changes in Dosage of medications taken to treat Parkinson's disease.
Changes in Participants medications taken

Full Information

First Posted
July 16, 2021
Last Updated
August 2, 2023
Sponsor
Hope Biosciences Stem Cell Research Foundation
Collaborators
Hope Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT04995081
Brief Title
Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD)
Official Title
A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hope Biosciences Stem Cell Research Foundation
Collaborators
Hope Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple allogeneic HB-adMSCs vs Placebo for the treatment of Parkinson's disease.
Detailed Description
The trial includes a screening period of up to 4 weeks, a 32- week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration. This clinical trial will be open to enroll 60 eligible participants diagnosed with Parkinson's disease. Patients' recruitment will be conducted by the study team, if eligible participants are identified based on eligibility criteria, a screening visit will be scheduled. Informed consent form will be given to the study participants and signed before any study procedures. Informed consent form will include information about the clinical trial and some aspects should be considered during this process. After Informed consent has been obtained, each participant should complete the following visits. Visit 1 - Screening, during this visit, the principal investigator will make the decision to determine whether the screened participant is eligible and whether the next visit can be scheduled. Once, the principal investigator has evaluated the eligibility of the subject screened (up to 28 days), a randomization process will be conducted in order to assign the eligible subject either allogeneic HB-adMSCs or placebo. Randomization will only apply to eligible subjects. If a study participant does not meet the inclusion and exclusion criteria during the screening process, he/she will be considered Screen Failure (SF) and randomization is not required. Visit 2 - Infusion 1, (Baseline): this visit will be used as a starting point for comparison of participant's data. During this visit, eligible study participants will receive his/her first investigational product administration or placebo with monitoring of vital signs for a total of 2 hours after drug exposure. Other study evaluations will be completed as part of this visit. Visit 3 - Infusion 2: approximately 4 weeks after the initial investigational product administration this visit should be completed. Other study evaluations will be completed as part of this visit. Visit 4 - Infusion 3: approximately 8 weeks after the initial investigational product administration this visit should be completed. Other study evaluations will be completed as part of this visit. Visit 5 - Infusion 4: approximately 12 weeks after the initial investigational product administration this visit should be completed. Other study evaluations will be completed as part of this visit. Visit 6 - Infusion 5: approximately 16 weeks after the initial investigational product administration this visit should be completed. Other study evaluations will be completed as part of this visit. Visit 7 - Infusion 6: approximately 20 weeks after the initial investigational product administration this visit should be completed. Other study evaluations will be completed as part of this visit. Phone Call - Safety Follow Up: approximately 24 weeks after the initial investigational product administration, active study participants will complete a phone call follow up. Phone Call - Safety Follow Up: approximately 32 weeks after the initial investigational product administration, active study participants will complete a phone call follow up. Visit 8 - End of Study, during this final visit (approximately 52 weeks after Week 0) a complete group of study assessments will be performed to evaluate the safety and efficacy of allogeneic HB-adMSCs or Placebo administrations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A parallel study is a type of clinical study where two groups of treatments, A (allogeneic HB-adMSCs) and B (Placebo), are given so that one group receives only A while another group receives only B.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Study subjects, investigators and study staff will be blinded to the assigned treatment.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Allogeneic HB-adMSCs.
Arm Type
Active Comparator
Arm Description
Biological/Vaccine: Allogeneic HB-adMSCs Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify. Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered intravenously to study participants who qualify. Other Names: Sterile Saline Solution 0.9%
Intervention Type
Biological
Intervention Name(s)
Biological/Vaccine: Allogeneic HB-adMSCs
Other Intervention Name(s)
Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
Intervention Description
HB-adMSCs will be administered intravenously to study participants who qualify.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo will be administered intravenously to study participants who qualify.
Intervention Description
Sterile Saline Solution 0.9%
Primary Outcome Measure Information:
Title
1. Changes in the total score MDS-UPDRS Part II.
Description
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II.
Time Frame
Baseline to Weeks 52.
Title
2. Incidence of treatment-emergent Adverse Event (TEAEs).
Description
Treatment-emergent Adverse Event.
Time Frame
Baseline to Weeks 52.
Title
3. Incidence of treatment-emergent Serious Adverse Events (SAEs).
Description
SSAEs.
Time Frame
Baseline to Weeks 52.
Title
4. AEs of special interest (serious or non-serious) - thromboembolic events.
Description
Incidence of thromboembolic events.
Time Frame
Baseline to Weeks 52.
Title
5. AEs of special interest (serious or non-serious) - thromboembolism of the extremities
Description
Incidence and risk of AEs of special interest (serious or non-serious), including peripheral events defined as, thromboembolism of the extremities.
Time Frame
Baseline to Weeks 52.
Title
6. AEs of special interest (serious or non-serious) - infections
Description
Incidence and risk of AEs of special interest (serious or non-serious), including infections.
Time Frame
Baseline to Weeks 52.
Title
7. AEs of special interest (serious or non-serious) - hypersensitivities.
Description
Incidence and risk of AEs of special interest (serious or non-serious), including hypersensitivities.
Time Frame
Baseline to Weeks 52.
Title
8. Laboratory value Complete Blood Count (CBC)
Description
Clinically significant changes in CBC values.
Time Frame
Baseline to Weeks 52.
Title
9. Laboratory values Chemistry Metabolic Panel (CMP)
Description
Number of Participants with changes in Laboratory CMP values
Time Frame
Baseline to Weeks 52.
Title
10. Laboratory values Coagulation Panel; Prothrombin time, Partial Prothrombin time, and INtern
Description
Number of Participants with changes in Laboratory Coagulation Panel values.
Time Frame
Baseline to Weeks 52.
Title
11. Vital signs. - Respiratory Rate (breaths per minute)
Description
Number of Participants with Clinically significant changes in Respiratory Rate.
Time Frame
Baseline to Weeks 52.
Title
12. Vital signs. - Heart Rate (beats per minute)
Description
Number of Participants with Clinically significant changes in Heart Rate.
Time Frame
Baseline to Weeks 52.
Title
13. Vital signs. - Body Temperature (Fahrenheit )
Description
Number of participants with Clinically significant changes in Heart Rate.
Time Frame
Baseline to Weeks 52.
Title
14. Vital signs. - Blood Pressure (mmHg)
Description
Number of Participants with Clinically significant changes in Blood Pressure.
Time Frame
Baseline to Weeks 52.
Title
15. Weight in lb.
Description
Number of Participants with Clinically significant changes in Weight in lb.
Time Frame
Baseline to Weeks 52.
Title
16. Physical examination results. General
Description
Number of Participants with Clinically significant changes in general physical examination results.
Time Frame
Baseline to Weeks 52.
Title
17. Physical examination results. Body Systems.
Description
Number of Participants with Clinically significant changes in body systems physical examination results.
Time Frame
Baseline to Weeks 52.
Secondary Outcome Measure Information:
Title
18. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale -UPDRS Part I.
Description
Changes in MDS-UPDRS Part I
Time Frame
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Title
19. Changes in the total score Movement Disorder Society Unified Parkinson's Disease Rating Scale -UPDRS Part II and Part III.
Description
Changes in Total score MDS-UPDRS Part II and Part III
Time Frame
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Title
20. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part III.
Description
Changes in MDS-UPDRS Part III
Time Frame
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Title
21. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part IV.
Description
Changes in MDS-UPDRS Part IV
Time Frame
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Title
22. Changes in Short Form 36 Health Survey Questionnaire (SF-36).
Description
Changes in SF-36
Time Frame
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Title
23. Changes in Parkinson's disease fatigue scale (PFS-16)
Description
Improvements in Participants PFS-16 scores
Time Frame
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Title
24. Changes in Parkinson's disease Questionnaire (PDQ-39).
Description
Improvements in Participants PDQ-39 scores
Time Frame
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Title
25. Changes in Visual Analog Scale for Pain.
Description
Changes in Participants VAS Pain Scales
Time Frame
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Title
26. Changes in Visual Analog Scale for Muscle spasms.
Description
Changes in Participants VAS spasms Scale
Time Frame
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Title
27. Changes in Dosage of medications taken to treat Parkinson's disease.
Description
Changes in Participants medications taken
Time Frame
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A study participant will be eligible for inclusion in this study only if all the following criteria apply: Male and female participants 45 - 80 years of age. At the screening visit, study participants must have an MDS-UPDRS part II score between 7 and 28. Study participants must have an MDS-UPDRS part III score between 20 and 57 during the screening visit. Carbidopa/Levodopa total dosage must be less than 1200 mg per day for study participants. The total Levodopa equivalent dose for study participants must be less than 1400 mg per day. Study participant must have been diagnosed with early and/or moderate Parkinson's disease at least 2 years prior study participation. Study participants should be able to read, understand and to provide written consent. Voluntarily signed informed consent obtained before any clinical-trial related procedures are performed. Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration. Male participants if their sexual partners can become pregnant should use a method of contraception during study participation and for 6 months after the last administration of the investigated product. Study participant is able and willing to comply with the requirements of this clinical trial. Exclusion Criteria: A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply: Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures. Study participants with advanced Parkinson's disease described as, severe disability, wheelchair bound or bedridden. Study participant has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma. Study participant has known alcoholic addiction or dependency or has current substance use or abuse. Study participant has 1 or more significant concurrent medical conditions (verified by medical records), including the following: Poorly controlled diabetes mellitus (PCDM) defined as history of deficient standard of care treatment and/or pre-prandial glucose >130mg/dl during screening visit or post-prandial glucose >200mg/dl. Medical History of Chronic kidney disease (CKD) diagnosis and/or screening results of eGFR < 59mL/min/1.73m2. Presence of New York Heart Association (NYHA) Class III/IV heart failure during screening visit. Any medical history of myocardial infarction in any of the different types, such as ST-elevation myocardial infarction (STEMI) or non-ST-elevated myocardial infarction (NSTEMI), coronary spasm, or unstable angina. Medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure > 180/120 mm/Hg during screening visit. Medical history of inherited thrombophilias, recent major general surgery, (within 12 months before the Screening), lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips or femur, cancer of the lung, brain, lymphatic, gynecologic system (ovary or uterus), or gastrointestinal tract (like pancreas or stomach). History of brain surgery for Parkinson's disease. Study participant has received any stem cell treatment within 6 months before first dose of investigational product other than stem cells produced by Hope Biosciences. Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines. Study participant has a laboratory abnormality during screening, including the following: White blood cell count < 3000/mm3 Platelet count < 80,000mm3 Absolute neutrophil count < 1500/mm3 Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 10 upper limit of normal (ULN) x 1.5 Study participant has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study. Study participant is unlikely to complete the study or adhere to the study procedures. Study participant with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection. Study participant has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments. Study participant with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product. Male study participants who plan to donate sperm during the study or within 6 months after the last dose. Female patients who plan to donate eggs or undergo in vitro fertilization treatment during the study or within 6 months after the last dose.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherry L Diers, RN
Phone
346-900-0340
Ext
101
Email
sherry@hopebio.org
First Name & Middle Initial & Last Name or Official Title & Degree
David T Gonzalez,, RN
Phone
346-900-0340
Ext
101
Email
david@hopebio.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Djamchid Lotfi, MD
Organizational Affiliation
Hope Biosciences Stem Cell Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hope Biosciences Stem Cell Research Foundation
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry L Diers, RN
Phone
346-900-0340
Ext
101
Email
sherry@hopebio.org
First Name & Middle Initial & Last Name & Degree
David T Gonzalez, RN
Phone
346-900-0340
Ext
101
Email
david@hopebio.org
First Name & Middle Initial & Last Name & Degree
Djamchid Lotfi, MD
First Name & Middle Initial & Last Name & Degree
Thanh Cheng, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30540129
Citation
Cuenca L, Gil-Martinez AL, Cano-Fernandez L, Sanchez-Rodrigo C, Estrada C, Fernandez-Villalba E, Herrero MT. Parkinson's disease: a short story of 200 years. Histol Histopathol. 2019 Jun;34(6):573-591. doi: 10.14670/HH-18-073. Epub 2018 Dec 12.
Results Reference
background
PubMed Identifier
22229124
Citation
Goetz CG. The history of Parkinson's disease: early clinical descriptions and neurological therapies. Cold Spring Harb Perspect Med. 2011 Sep;1(1):a008862. doi: 10.1101/cshperspect.a008862.
Results Reference
background
PubMed Identifier
30702835
Citation
Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK536721/
Results Reference
background
PubMed Identifier
25904081
Citation
Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
Results Reference
background
PubMed Identifier
32044947
Citation
Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.
Results Reference
background
PubMed Identifier
28494719
Citation
Tambasco N, Romoli M, Calabresi P. Levodopa in Parkinson's Disease: Current Status and Future Developments. Curr Neuropharmacol. 2018;16(8):1239-1252. doi: 10.2174/1570159X15666170510143821.
Results Reference
background
PubMed Identifier
9358193
Citation
Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.
Results Reference
background
PubMed Identifier
31569696
Citation
Coppin L, Sokal E, Stephenne X. Thrombogenic Risk Induced by Intravascular Mesenchymal Stem Cell Therapy: Current Status and Future Perspectives. Cells. 2019 Sep 27;8(10):1160. doi: 10.3390/cells8101160.
Results Reference
background
PubMed Identifier
23313481
Citation
Tatsumi K, Ohashi K, Matsubara Y, Kohori A, Ohno T, Kakidachi H, Horii A, Kanegae K, Utoh R, Iwata T, Okano T. Tissue factor triggers procoagulation in transplanted mesenchymal stem cells leading to thromboembolism. Biochem Biophys Res Commun. 2013 Feb 8;431(2):203-9. doi: 10.1016/j.bbrc.2012.12.134. Epub 2013 Jan 9.
Results Reference
background
PubMed Identifier
31018669
Citation
Musial-Wysocka A, Kot M, Majka M. The Pros and Cons of Mesenchymal Stem Cell-Based Therapies. Cell Transplant. 2019 Jul;28(7):801-812. doi: 10.1177/0963689719837897. Epub 2019 Apr 24.
Results Reference
background
PubMed Identifier
30858851
Citation
Garretti F, Agalliu D, Lindestam Arlehamn CS, Sette A, Sulzer D. Autoimmunity in Parkinson's Disease: The Role of alpha-Synuclein-Specific T Cells. Front Immunol. 2019 Feb 25;10:303. doi: 10.3389/fimmu.2019.00303. eCollection 2019.
Results Reference
background
PubMed Identifier
19926330
Citation
Meirelles Lda S, Fontes AM, Covas DT, Caplan AI. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009 Oct-Dec;20(5-6):419-27. doi: 10.1016/j.cytogfr.2009.10.002. Epub 2009 Nov 18.
Results Reference
background
PubMed Identifier
15684121
Citation
Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. doi: 10.1503/cmaj.1040752.
Results Reference
background
PubMed Identifier
32332985
Citation
Tan EK, Chao YX, West A, Chan LL, Poewe W, Jankovic J. Parkinson disease and the immune system - associations, mechanisms and therapeutics. Nat Rev Neurol. 2020 Jun;16(6):303-318. doi: 10.1038/s41582-020-0344-4. Epub 2020 Apr 24.
Results Reference
background
PubMed Identifier
24027567
Citation
Dimarino AM, Caplan AI, Bonfield TL. Mesenchymal stem cells in tissue repair. Front Immunol. 2013 Sep 4;4:201. doi: 10.3389/fimmu.2013.00201.
Results Reference
background
PubMed Identifier
21303266
Citation
Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
Results Reference
background

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Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD)

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