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Own stem cells infused to fight Parkinson's in elderly

NCT ID NCT04772378

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This program gave 10 people with Parkinson's disease, aged 76 to 95, multiple infusions of their own stored stem cells to check if it is safe. The treatment used 200 million cells given through an IV over 18 weeks, followed by 6 weeks of monitoring. The goal was safety, not a cure, and participants needed to have previously banked their stem cells with the sponsor.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

76 to 95 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria A participant will be eligible for inclusion in this expanded access program only if all the following criteria apply: 1. Patients aged 76-95 years old (male and female). 2. Patients must have had a Parkinson's disease diagnosis for a minimum of six months before 1st infusion. 3. Patients must have previously banked their mesenchymal stem cells with Hope Biosciences. 4. Patients should be able to read, understand, and provide voluntarily written consent. 5. Patients able and willing to comply with the requirements of this expanded access program. Exclusion Criteria A participant will not be eligible for inclusion in this expanded access program if any of the following criteria apply: 1. Patients with advanced Parkinson's disease. Advanced PD is defined as a significant disability, wheelchair-bound or bedridden. 2. 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. 3. 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. 4. 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. 5. 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 6. Patients who have received any stem cell treatment in the past six months before 1st infusion other than stem cells produced by Hope Biosciences. 7. Patients who are unlikely to complete the visits or adhere to the procedures. 8. The patient has previously been diagnosed with a psychiatric disorder, which is currently uncontrolled. 9. Patients with a history of addiction or dependency or currently abusing or using substances. 10. Patients with any form of kidney dialysis will be excluded from participation in the investigation. 11. 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). 12. 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. 13. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hope Biosciences Stem Cell Research Foundation

    Sugar Land, Texas, 77478, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.