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Could stem cells slow Huntington's? new trial tests cellavita HD

NCT ID NCT03252535

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tested a stem cell therapy called Cellavita HD in 49 people with Huntington's disease. Participants received either a low dose, high dose, or placebo through IV infusions over several months. The study measured changes in motor skills to see if the treatment could slow the disease's progression.

What this could mean

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

Active substance
Cellavita HD (mesenchymal stem cells)
What this could lead to
If successful, this could point toward a treatment that slows or improves motor decline in Huntington's disease.
What could go wrong
This is a small, early-phase trial with only 49 participants. Results may not be conclusive, and stem cell therapies carry risks like immune reactions or unknown long-term effects.

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

49 people

The number who actually took part.

Started

Jan 2018

Finished

Apr 2021

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

21 to 65 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: 1. Provide a written, signed and dated Informed Consent Form; 2. Male and female subjects aged ≥ 21 and ≤ 65 years; 3. Have a confirmatory diagnosis report (PCR) of Huntington's disease with a number of CAG repeats in chromosome 4 higher than or equal to 40, and lower than or equal to 50 (if the subject did not perform the exam and/or if he/she does not have an available result for this exam, a new exam must be performed); 4. A score of 5 points or higher for the motor evaluation of the UHDRS scale (Unified Huntington's Disease Rating Scale) at enrollment; 5. Score of 8 to 11 points for the functional capacity of the UHDRS scale at enrollment. Exclusion Criteria: 1. Subject who participated in clinical trials protocols within the last twelve (12) months (Resolution CNS 251, August 7, 1997, item III, subitem J), unless, at the investigator's opinion, the subject would have a direct benefit from it; 2. Diagnosis of juvenile Huntington's disease; 3. Diagnosis of epilepsy; 4. Diagnosis of major cognitive disorder; 5. Active decompensated psychiatric illness; 6. Current or prior history of neoplasm; 7. Current history of gastrointestinal, hepatic, renal, endocrine, pulmonary, hematological, immunological, metabolic pathology or severe uncontrolled cardiovascular diseases; 8. Diagnosis of any active infection, whether viral, bacterial, fungal or caused by another pathogen; 9. Subject with contraindication to the exams performed in this study, for example, with pacemaker or surgical clip; Alcohol and drugs abuse (previously diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders - DSM V criteria); 10. Use of illegal drugs; 11. Tabagism; 12. Smoker or quit smoking for less than 6 months; 13. Positive result in one of the serum tests: HIV 1 and 2 (Anti-HIV-1,2), HTLV I and II, HBV (HBsAg, Anti-HBc), HCV (anti-HCV-Ab) and FTA-ABS (Treponema pallidum); 14. History of drug allergy, including to contrast agents used in imaging tests or bovine-derived products; 15. Using or expects to use immunosuppressant drugs or forbidden drugs (item 5.3) during the first three months after the first administration of the investigational product; 16. Any clinical change that the investigator considers a risk to subject's enrollment in the study.

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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

  • Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.

    Valinhos, São Paulo, 13271-130, Brazil

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