Intermediate Size Patient Population Expanded Access IND for the Treatment of Patients With Parkinson's Disease.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04772378|
Expanded Access Status : Available
First Posted : February 26, 2021
Last Update Posted : August 2, 2022
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|Condition or disease||Intervention/treatment|
|Parkinson Disease||Biological: HB-adMSCs|
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients|
|Official Title:||An Intermediate Size Patient Population Expanded Access IND to Evaluate the Safety of Autologous HB-adMSCs for the Treatment of Patients With Parkinson's Disease.|
- Biological: HB-adMSCs
HB-adMSCs (Hope Biosciences autologous adipose-derived mesenchymal stem cells) is manufactured by Hope Biosciences, L.L.C., a biotechnology company headquartered in Sugar Land, Texas.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||76 Years to 95 Years (Older Adult)|
|Sexes Eligible for Study:||All|
A participant will be eligible for inclusion in this expanded access program only if all the following criteria apply:
- Patients aged 76-95 years old (male and female).
- Patients must have had a Parkinson's disease diagnosis for a minimum of six months before 1st infusion.
- Patients must have previously banked their mesenchymal stem cells with Hope Biosciences.
- Patients should be able to read, understand, and provide voluntarily written consent.
- Patients able and willing to comply with the requirements of this expanded access program.
A participant will not be eligible for inclusion in this expanded access program if any of the following criteria apply:
- Patients with advanced Parkinson's disease. Advanced PD is defined as a significant disability, wheelchair-bound or bedridden.
- Any malignancy or clinical evidence that supports the presence of a malignant process in a patient is being investigated. Malignancy is defined as any form of cancer that had occurred in the previous five years before the first infusion and may require surgery, chemotherapy, or radiation.
- Patients with medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure > 140/90 mm/Hg during screening visit.
Patients with the following concomitant or past medical history:
- Heart Failure - New York Heart Association (NYHA) Class III/IV.
- Heart Attack (in the past six months before 1st infusion).
- Stroke (in the past six months before 1st infusion).
- Hepatitis B or C.
- Human immunodeficiency virus (HIV) infection.
Any of the following abnormal lab findings during screening will disqualify a patient from this expanded access program:
- Hemoglobin (Hgb) <10 G/DL or >18 G/DL
- Hematocrit (HCT) <30% or >54 %
- Platelet count < 80 K/UL and or > 450 K/UL.
- White blood cell count WBC < 3.0 K/UL and > 12.0 K/UL.
- Alanine aminotransferase (ALT) of > 75 IU/L
- Aspartate aminotransferase (AST) of > 75 IU/L
- eGFR < 59 mL/min/1.73
- Pre-prandial glucose > 130 MG/DL
- Post-prandial glucose > 200 MG/DL
- Patients who have received any stem cell treatment in the past six months before 1st infusion other than stem cells produced by Hope Biosciences.
- Patients who are unlikely to complete the visits or adhere to the procedures.
- The patient has previously been diagnosed with a psychiatric disorder, which is currently uncontrolled.
- Patients with a history of addiction or dependency or currently abusing or using substances.
- Patients with any form of kidney dialysis will be excluded from participation in the investigation.
- Patients who have received an experimental drug in the past 12 months before the first dose of the investigational product. (Except for COVID-19 vaccinations).
- Patients who the Investigator determines to be unsuitable for participation for other reasons, such as, but not limited to deep vein thrombosis (DVT), pulmonary embolus, cardiac arrhythmia, or those who have a prothrombotic condition, or who require persistent oxygen supplementation.
- Patients who have recently undergone major surgery (in the past six months before 1st infusion). Some examples of major surgeries include, but are not limited to, the following: heart surgeries, aortic aneurysm bypass, organ transplant, intracranial surgery, spinal laminectomy or fusion, amputation, resection of the lung, resection of esophagus, resection of a mediastinal mass, resection of bladder or prostate tumor and resection of kidney or ureter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772378
|Contact: Sherry Diers, RN||(346) 900 0340 ext email@example.com|
|Contact: David Gonzalez, RN||(346) 900 0340 ext firstname.lastname@example.org|
|United States, Texas|
|Hope Biosciences Stem Cell Research Foundation||Available|
|Sugar Land, Texas, United States, 77478|
|Contact: Sherry Diers, RN 346-900-0340 ext 101 email@example.com|
|Contact: David Gonzalez, RN 1-346-900-0340 ext 101 firstname.lastname@example.org|
|Principal Investigator: Djamchid Lotfi, MD|
|Sub-Investigator: Thanh Cheng, MD|
|Principal Investigator:||Djamchid Lotfi, MD||Hope Biosciences Stem Cell Research Foundation|
|Responsible Party:||Hope Biosciences Stem Cell Research Foundation|
|Other Study ID Numbers:||
|First Posted:||February 26, 2021 Key Record Dates|
|Last Update Posted:||August 2, 2022|
|Last Verified:||July 2022|
Mesenchymal Stem Cells
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