Could stem cells slow Huntington's? new trial tests cellavita HD
NCT ID NCT03252535
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 Hide 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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