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Stem cell infusions aim to slow Parkinson's progression

NCT ID NCT04506073

Disease control Sponsor: Mya Schiess Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether repeat infusions of stem cells from healthy donors can slow the progression of Parkinson's disease. About 45 people with Parkinson's will receive either one of two doses of these stem cells or a placebo. Researchers will measure changes in motor symptoms over about a year to see if the treatment helps. The goal is to find a safe and effective dose that could modify the course of the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
allogeneic bone marrow-derived mesenchymal stem cells
What this could lead to
If repeat stem cell infusions slow Parkinson's motor decline, this could point toward a disease-modifying therapy that delays disability.
What could go wrong
This is a small Phase 2 trial, so results may not hold up in larger studies. Stem cell infusions carry risks like allergic reactions or organ stress, and the treatment may not slow the disease.

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

45 people

The number who actually took part.

Started

Nov 2020

Finished

Jul 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

50 to 79 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: * Diagnosis of Parkinson's disease by the UK brain bank criteria including the presence of 2 cardinal signs of PD plus bradykinesia. * Mild microsomia to anosmia. * A modified Hoehn and Yahr stage of 3 or less. * Date of diagnosis of PD between 3 to 10 years * Robust response to dopaminergic therapy. Exclusion Criteria: * Atypical, vascular, or drug-induced Parkinsonism. * An atypical DAT scan or MRI supporting an alternative explanation for PD symptoms. * Patient not on levodopa containing medications. * Clinical features of psychosis or refractory hallucinations. * A Montreal Cognitive Assessment (MoCA) score of less than 25. * Uncontrolled seizure disorder. * Abnormal Kidney and liver function. * Presence of clinically refractory orthostatic hypotension at the screening or baseline visit. * Body mass index of greater than or equal to 35. * Cardiac disease: History of congestive heart failure, clinically significant bradycardia, presence of 2nd, or 3rd-degree atrioventricular block. * Pulmonary disease: COPD with oxygen-requirement at rest or with ambulation; or moderate to severe asthma. * Active malignancy or diagnosis of malignancy within 5 years prior to the start of screening * Any current suicidal ideation or behaviors. * Any diagnosis of autoimmune disease or immunocompromised state * History of medium or large size vessel cerebrovascular accidents. * History of traumatic brain injury with loss of consciousness and residual neurologic symptoms. * Major surgery within the previous 3 months or planned in the ensuing 6 months. * History of use of an investigational drug within 90 days prior to the screening visit. * History of brain surgery for PD. * Substance abuse disorder. * Active anticoagulation treatment and/or abnormal INR.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

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

Parkinson's disease

Contacts and locations

Locations

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

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