A Phase 2 interventional study of Cellavita HD lower dose and Cellavita HD higher dose in Huntington Disease, sponsored by Azidus Brasil. Completed at 1 site in Brazil. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Azidus Brasil · Phase 2, Interventional, and Treatment
Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a prospective, phase II, single-center, randomized (2:2:1), triple-blind, placebo controlled study, with two test doses of Cellavita HD product.
This is a phase II dose-response study in which participants with HD will receive three intravenous injections of the investigational product or placebo (one every month for three months) a total of three cycles. The subjects will be randomized in 2: 2: 1 ratio for the groups G1: lower dose (1x10\^6 cells/weight range), G2: higher dose (2x10\^6 cells/weight range) or G3: placebo. To identify the dose of the product that will provide the best clinical response, motor assessment will be performed with UHDRS scale and improvement will be evaluated by correlating before and after treatment scores. Additionally, also will be performed the combined score through the cUHDRS. Secondary evidences of efficacy will be evaluated through the data of functional state, total functional capacity, functional independence, psychiatric symptoms and cognition from UHDRS scale. Additionally, related data to clinical worsening, change of Body Mass Index (BMI), risk of suicide attempt and neurological image improvement will be evaluated. Safety evaluation will included the incidence and classification of the adverse events experienced by the subjects during the study.
293 studies on the registry are indexed under Huntington Disease; 54 are open to participants now.
This study's enrollment of 49 is above the median of 40 across 207 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →Azidus Brasil is the lead sponsor of 80 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Biological: Cellavita HD lower dose
The participants randomized to this group will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Biological: Cellavita HD higher dose
The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Other: Placebo
The participants will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Also known as: cellular therapy, mesenchymal stem cells
The participants will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Also known as: cellular therapy, mesenchymal stem cells
The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Also known as: physiological solution without cells
Efficacy by UHDRS-TMS
The primary endpoint was the rate of change (slope) in Unified Huntington's Disease Rating Scale - Total Motor Score from V0 to V11 (minimum 0, the best; and maximum 124, the worst). For each participant, a regression line was fitted (Y = a + bx), where b represents the individual slope, reflecting the annualised rate of motor progression. A negative slope suggests improvement or slower decline; a positive slope indicates worsening. To compare treatment efficacy, the slopes were analysed using a Mixed Model for Repeated Measures (MMRM), which accounts for intra-subject variability and missing data. This approach allowed estimation and comparison of average slopes between each treated group and placebo, providing a robust measure of motor function trajectory over time.
Time frame: monthly for eleven months
Efficacy by UHDRS-TFC
Assessed by the rate of change (slope) from V0 to V11 in the UHDRS-TFC. The response of each participant or means of all participants was evaluated by the slopes of each regression line of UHDRS-TFC determined as follows: The equation describes the regression line: Y = a + bx, where: * "Y" is the dependent variable. * "a" is the constant that represents the intersection of the line with the vertical axis. * "b" is the angular coefficient, that is, the slope. * "x" is the independent variable. Therefore, the 'b' value represents the slope of the straight line that best fits the values collected from the baseline (V0) to the value of V11, using the least squares method. This slope corresponds to the estimated annualized individual variation of UHDRS-TFC during the given period.
Time frame: monthly for eleven months
Exposure to NestaCell (Former Cellavita HD) Product
Number of administrations of NestaCell (Former Cellavita HD) and Placebo
Time frame: eleven months
| Milestone | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group |
|---|---|---|---|
| Started | 14 | 14 | 7 |
| Completed | 13 | 12 | 7 |
| Not completed | 1 | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Met discontinuation criteria | 0 | 1 | 0 |
The primary endpoint was the rate of change (slope) in Unified Huntington's Disease Rating Scale - Total Motor Score from V0 to V11 (minimum 0, the best; and maximum 124, the worst). For each participant, a regression line was fitted (Y = a + bx), where b represents the individual slope, reflecting the annualised rate of motor progression. A negative slope suggests improvement or slower decline; a positive slope indicates worsening. To compare treatment efficacy, the slopes were analysed using a Mixed Model for Repeated Measures (MMRM), which accounts for intra-subject variability and missing data. This approach allowed estimation and comparison of average slopes between each treated group and placebo, providing a robust measure of motor function trajectory over time.
| score on a scale/year | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group |
|---|---|---|---|
| Efficacy by UHDRS-TMS | -1.23 ± 0.84 | 0.84 ± 0.90 | 8.91 ± 1.11 |
Assessed by the rate of change (slope) from V0 to V11 in the UHDRS-TFC. The response of each participant or means of all participants was evaluated by the slopes of each regression line of UHDRS-TFC determined as follows: The equation describes the regression line: Y = a + bx, where: * "Y" is the dependent variable. * "a" is the constant that represents the intersection of the line with the vertical axis. * "b" is the angular coefficient, that is, the slope. * "x" is the independent variable. Therefore, the 'b' value represents the slope of the straight line that best fits the values collected from the baseline (V0) to the value of V11, using the least squares method. This slope corresponds to the estimated annualized individual variation of UHDRS-TFC during the given period.
| score on a scale/year | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group |
|---|---|---|---|
| Efficacy by UHDRS-TFC | -0.29 ± 0.18 | 0.73 ± 0.18 | -0.89 ± 0.26 |
Number of administrations of NestaCell (Former Cellavita HD) and Placebo
| number os adminstrations | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group |
|---|---|---|---|
| Exposure to NestaCell (Former Cellavita HD) Product | 9.0 ± 0.0 | 8.4 ± 1.5 | 9.0 ± 0.0 |
Collected over 11 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nestacell (Former Cellavita HD) Lower Dose | 0/14 (0%) | 1/14 (7.1%) | 12/14 (85.7%) |
| Nestacell (Former Cellavita HD) Higher Dose | 0/14 (0%) | 0/14 (0%) | 12/14 (85.7%) |
| Placebo Group | 0/7 (0%) | 0/7 (0%) | 7/7 (100%) |
| Event | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group |
|---|---|---|---|
| hospitalized for sinusitisInfections and infestations | 1/14 | 0/14 | 0/7 |
| Event | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group |
|---|---|---|---|
| AlopeciaSkin and subcutaneous tissue disorders | 5/14 | 2/14 | 0/7 |
| FallInjury, poisoning and procedural complications | 5/14 | 0/14 | 1/7 |
| DiarrheaGastrointestinal disorders | 1/14 | 1/14 | 2/7 |
| VomitGastrointestinal disorders | 0/14 | 0/14 | 2/7 |
| InsomniaPsychiatric disorders | 0/14 | 1/14 | 2/7 |
| DyslipidemiaMetabolism and nutrition disorders | 3/14 | 1/14 | 1/7 |
| InfluenzaRespiratory, thoracic and mediastinal disorders | 1/14 | 3/14 | 0/7 |
| Abnormal hair growthSkin and subcutaneous tissue disorders | 2/14 | 0/14 | 0/7 |
| WoundSkin and subcutaneous tissue disorders | 2/14 | 0/14 | 0/7 |
| Atopic dermatitisImmune system disorders | 0/14 | 0/14 | 1/7 |
| Age, Continuous(years) | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group | Total |
|---|---|---|---|---|
| Mean | 51.6 ± 9.4 | 43.7 ± 8.5 | 50.9 ± 9.7 | 48.7 ± 9.2 |
| Sex: Female, Male(Participants) | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group | Total |
|---|---|---|---|---|
| Female | 7 | 9 | 2 | 18 |
| Male | 7 | 5 | 5 | 17 |
| Race/Ethnicity, Customized(Participants) | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group | Total |
|---|---|---|---|---|
| Black | 2 | 1 | 0 | 3 |
| Multiracial | 3 | 3 | 3 | 9 |
| White | 9 | 9 | 4 | 22 |
| Other | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group | Total |
|---|---|---|---|---|
| Brazil | 14 | 14 | 7 | 35 |
| Height(meters) | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group | Total |
|---|---|---|---|---|
| Mean | 1.63 ± 0.08 | 1.61 ± 0.1 | 1.66 ± 0.06 | 1.63 ± 0.08 |
| Weight(Kg) | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group | Total |
|---|---|---|---|---|
| Mean | 65.5 ± 14.0 | 68.7 ± 14.5 | 69.3 ± 14.0 | 67.8 ± 14.2 |
| BMI(Kg/m^2) | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group | Total |
|---|---|---|---|---|
| Mean | 24.4 ± 4.5 | 26.4 ± 5.5 | 25.0 ± 4.4 | 25.3 ± 4.8 |
| CAG repeat(Participants) | Nestacell (Former Cellavita HD) Lower Dose | Nestacell (Former Cellavita HD) Higher Dose | Placebo Group | Total |
|---|---|---|---|---|
| <44 | 9 | 7 | 4 | 20 |
| >=44 | 5 | 7 | 3 | 15 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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