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Could your own stem cells ease Parkinson's? new trial results are in

NCT ID NCT04928287

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 This study
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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 phase 2 study tested whether a person's own stem cells (called HB-adMSCs) could help control Parkinson's disease symptoms. Twenty-four adults with early to moderate Parkinson's received either stem cell infusions or a placebo over 32 weeks, and were followed for safety. The main goal was to see if the treatment improved daily living skills and movement, as measured by standard Parkinson's rating scales. While the study is complete, it focused on safety and symptom control rather than a cure.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Jun 2021

Finished

Feb 2023

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 study participant will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male and female participants 18 - 75 years of age. 2. Study participant must have been diagnosed with early and/or moderate Parkinson's disease at least 6 months before study participation. 3. Study participants must have previously banked their mesenchymal stem cells with Hope Biosciences. 4. Study participants should be able to read, understand and to provide written consent. 5. Voluntarily signed informed consent obtained before any clinical-trial related procedures are performed. 6. Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration. 7. 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. 8. 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 hepatitis 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. 15. Study participants who are determined by the Investigator to be unsuitable for study enrollment for other reasons

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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.