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

NCT04995081 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: HBPD04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (18)

• 1. Changes in the total score MDS-UPDRS Part II.

  Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II.

  Baseline to Weeks 52.

• 2. Changes in the total score MDS-UPDRS Part III.

  Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III.

  Baseline to Weeks 52.

• 3. Incidence of treatment-emergent Adverse Event (TEAEs).

  Treatment-emergent Adverse Event.

  Baseline to Weeks 52.

• 4. Incidence of treatment-emergent Serious Adverse Events (SAEs).

  SSAEs.

  Baseline to Weeks 52.

• 5. AEs of special interest (serious or non-serious) - thromboembolic events.

  Incidence of thromboembolic events.

  Baseline to Weeks 52.

• 6. 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.

  Baseline to Weeks 52.

• 7. AEs of special interest (serious or non-serious) - infections

  Incidence and risk of AEs of special interest (serious or non-serious), including infections.

  Baseline to Weeks 52.

• 8. AEs of special interest (serious or non-serious) - hypersensitivities.

  Incidence and risk of AEs of special interest (serious or non-serious), including hypersensitivities.

  Baseline to Weeks 52.

• 9. Laboratory value Complete Blood Count (CBC)

  Clinically significant changes in CBC values.

  Baseline to Weeks 52.

• 10. Laboratory values Chemistry Metabolic Panel (CMP)

  Number of Participants with changes in Laboratory CMP values

  Baseline to Weeks 52.

• 11. Laboratory values Coagulation Panel; Prothrombin time, Partial Prothrombin time, and INtern

  Number of Participants with changes in Laboratory Coagulation Panel values.

  Baseline to Weeks 52.

• 12. Vital signs. - Respiratory Rate (breaths per minute)

  Number of Participants with Clinically significant changes in Respiratory Rate.

  Baseline to Weeks 52.

• 13. Vital signs. - Heart Rate (beats per minute)

  Number of Participants with Clinically significant changes in Heart Rate.

  Baseline to Weeks 52.

• 14. Vital signs. - Body Temperature (Fahrenheit )

  Number of participants with Clinically significant changes in Heart Rate.

  Baseline to Weeks 52.

• 15. Vital signs. - Blood Pressure (mmHg)

  Number of Participants with Clinically significant changes in Blood Pressure.

  Baseline to Weeks 52.

• 16. Weight in lb.

  Number of Participants with Clinically significant changes in Weight in lb.

  Baseline to Weeks 52.

• 17. Physical examination results. General

  Number of Participants with Clinically significant changes in general physical examination results.

  Baseline to Weeks 52.

• 18. Physical examination results. Body Systems.

  Number of Participants with Clinically significant changes in body systems physical examination results.

  Baseline to Weeks 52.

Secondary Outcomes (10)

• 19. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale -UPDRS Part I.

  Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.

• 20. Changes in the total score Movement Disorder Society Unified Parkinson's Disease Rating Scale -UPDRS Part II and Part III.

  Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.

• 21. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part III.

  Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.

• 22. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part IV.

  Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.

• 23. Changes in Short Form 36 Health Survey Questionnaire (SF-36).

  Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.

Study Arms (2)

Allogeneic HB-adMSCs.

ACTIVE COMPARATOR

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.

Biological: Biological/Vaccine: Allogeneic HB-adMSCs; Other: Placebo

Placebo

PLACEBO COMPARATOR

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

Biological: Biological/Vaccine: Allogeneic HB-adMSCs; Other: Placebo

Interventions

Biological/Vaccine: Allogeneic HB-adMSCs BIOLOGICAL

HB-adMSCs will be administered intravenously to study participants who qualify.

Also known as: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.

Allogeneic HB-adMSCs.; Placebo

Placebo OTHER

Sterile Saline Solution 0.9%

Also known as: Placebo will be administered intravenously to study participants who qualify.

Allogeneic HB-adMSCs.; Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, 77478, United States

Location

Related Publications (16)

• 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.

  PMID: 30540129 BACKGROUND

• 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.

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• 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/

  PMID: 30702835 BACKGROUND

• 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.

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• 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.

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• 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.

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• Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Parkinson Disease

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Djamchid Lotfi, MD

  Hope Biosciences Stem Cell Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study subjects, investigators and study staff will be blinded to the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 6, 2021
• Study Start: July 16, 2021
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)