Autism Spectrum DisorderPhase 2NCT06629324
Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy From Brain Hypoxia
A Phase 2 study testing Autologous Bone Marrow Mononuclear Cell Transfusion and Rehabilitation in people with Autism Spectrum Disorder, run by Vinmec Research Institute of Stem Cell and Gene Technology at 2 sites in Vietnam.
Trial summary
This clinical trial aims to evaluate the effectiveness of autologous bone marrow mononuclear cell transfusion in treating cerebral palsy caused by cerebral hypoxia. The key questions the study seeks to answer are: What is the safety profile in terms of adverse events (AE) and serious adverse events (SAE) observed over… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Autologous Bone Marrow Mononuclear Cell Transfusion and Rehabilitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 2 sitesVietnam
- Study dates
- 15 Oct 2024to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 1 to 10 years, both genders;
- Gross Motor Function Classification System (GMFCS): levels II to V;
- Spastic cerebral palsy due to brain hypoxia.
Who cannot join
- Coagulation disorders;
- Severe health conditions such as cachexia, heart failure, lung, liver, or kidney failure; or active infections;
- Spinal injuries prevent the placement of a catheter through the spinal cavity;
- Cancer;
- HIV positive, active viral hepatitis;
- Hemoglobin below 110 g/L.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
Vinmec research Institute and Gene Technology
Hanoi, 100000
Thanh Liem Nguyen, 0986565015, phuong.nh2@vinuni.edu.vn
- Not yet recruiting
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, 100000
Liem T Nguyen, MD, PhD,, +84-091-691-1897, v.liemnt@vinmec.com
Phuong H Nguyen, MPH, +84-091-474-0683, v.phuongnh9@vinmec.com
About this study
Official title: Evaluation of the Efficacy of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in the Treatment of Cerebral Palsy Due to Brain Hypoxia: A Phase II Randomized Clinical Trial
This clinical trial aims to evaluate the effectiveness of autologous bone marrow mononuclear cell transfusion in treating cerebral palsy caused by cerebral hypoxia.
The key questions the study seeks to answer are:
Read more
- What is the safety profile in terms of adverse events (AE) and serious adverse events (SAE) observed over the 9 months following the first transplantation?
- How does autologous bone marrow mononuclear cell (BM MNC) transplantation impact the gross motor function (GMFM-88) scores and Gross Motor Function Classification System (GMFCS) scores in children with cerebral palsy?
- How does autologous BM MNC transplantation influence muscle tone (Modified Ashworth Scale score) and hand motor function (MACS/Mini-MACS scale) in children with cerebral palsy, 9 months post the initial transplantation?
Fifty-eight selected patients, aged 1 to 10 years and diagnosed with spastic cerebral palsy due to brain hypoxia, will be randomly divided into two groups:
- Group A: will receive two BM MNC infusions with the first at baseline and the second at 6 months ± 21 days (T6) via the spinal route.
- Group B: will serve as the control group for the first 9 months. During this period, patients will not receive cell transplantation but will undergo a similar rehabilitation and medication regimen as Group A. After 9 months, Group B will receive two BM MNC infusions: the first at 9 months ± 21 days (T9) and the second at 15 months ± 21 days (T15) via the spinal route, with a follow-up at 18 months ± 21 days (T18) compared to baseline.
- Both groups: will undergo rehabilitation for 10 days per month, three times, either at rehabilitation centers or performed by a rehabilitation technician at home. After this period, continued training will be conducted by family members. The combined medication regimen will include muscle relaxants (if muscle spasticity is present), vitamins, and neuroprotective drugs (Piracetam).
Read the detailed description
Cerebral Palsy (CP) is one of the most common causes of motor disability in children, significantly affecting their quality of life (QOL). Children with CP often face various challenges, including motor, sensory, and communication difficulties [1]. Recent studies suggest that autologous bone marrow-derived mononuclear cells (BM MNCs) show promise in improving motor function and reducing muscle spasticity in CP children [2, 3, 4]. The effects of BM MNC transplantation on the quality of life in CP children and their families remain understudied, despite improvements in motor function being reported.
Our Phase I study evaluated the safety and effects of autologous BM MNCs on the improvement of gross motor function and muscle tone in children with CP. This Phase II randomized clinical trial aims to evaluate the efficacy of autologous BM MNCs in children with CP at Vinmec International Hospital, Hanoi, Vietnam, from October 2024 to January 2027 [5]. The inclusion criteria are: (1) aged 1 to 10 years and of either sex; (2) having a Gross Motor Function Classification System (GMFCS) score ranging from level II to level V; and (3) spastic cerebral palsy due to cerebral hypoxia. Patients will be excluded if they have coagulation disorders; suffer from severe health conditions such as exhaustion, heart, lung, liver, or kidney failure, or active infections; have spinal injuries that prevent the administration of intrathecal injections; are diagnosed with cancer; test positive for HIV or have active viral hepatitis; or have hemoglobin levels below 110 g/L.
In total, 58 patients were randomly assigned to two groups. Randomization allocation was conducted using a random number table, and the ratio of participants in each group was 1:1. Group A will receive two BM MNC administrations: the first at baseline and the second at 6 months ± 21 days (T6) via intrathecal injection. Concomitantly, the CT group will undergo a 10-day-per-month rehabilitation program for 3 months, either at rehabilitation centers or with at-home therapy, followed by exercises managed by family members. Group B will serve as the control group for the first 9 months, receiving rehabilitation and medications similar to Group A but without BM MNC therapy. After 9 months, Group B will receive BM MNCs at 9 months ± 21 days (T9) and 15 months ± 21 days (T15), with outcomes evaluated at 18 months ± 21 days (T18) compared to baseline.
Bone marrow was collected under general anesthesia from both anterior superior iliac crests, taking 15-20 minutes, with a maximum volume of 350 mL for older children. Mononuclear cells were isolated using Ficoll density gradient centrifugation and prepared for infusion. The infusion, performed in the L4-L5 spinal space, lasted about 30 minutes at a rate of 20 mL per hour. Cerebrospinal fluid (CSF) was withdrawn before infusion, with the amount based on the child's weight. Patients received Rocephin for infection prevention and pain relief with alternating doses of Ibuprofen and Efferalgan for 2 days post-procedure. Seduxen was given once on the first night after bone marrow collection. The rehabilitation program included exercises for head and body control, muscle tone management, and facilitated movements based on developmental milestones. Occupational therapy focused on improving hand function and daily activities, while speech therapy addressed communication, comprehension, and chewing/swallowing abilities.
The safety of the therapy will be assessed by monitoring the frequency and severity of adverse events (AEs) and serious adverse events (SAEs). SAEs include events leading to death, life-threatening conditions, hospitalizations or prolonged hospital stays, significant or permanent disabilities, and congenital abnormalities or birth defects. Efficacy will be evaluated based on changes in gross motor function 9 months after the first BM MNC transplant. This will involve the GMFM-88 scale to assess gross motor function, the GMFCS scale to classify motor function severity, and the Mini-MACs (for children aged 1-4) and MACs (for children aged 4-18) scales to measure hand function. Additionally, muscle tone changes will be measured using the Modified Ashworth Scale 9 months post-transplant.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Autologous Bone Marrow Mononuclear Cell Transfusion, Rehabilitation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Bone Marrow Mononuclear Cell TransfusionBiological
Bone marrow was collected under general anesthesia from both anterior superior iliac crests, taking 15-20 minutes, with a maximum volume of 350 mL for older children. Mononuclear cells were isolated using Ficoll density gradient centrifugation and prepared for infusion. The infusion, performed in the L4-L5 spinal space, lasted about 30 minutes at a rate of 20 mL per hour. Cerebrospinal fluid (CSF) was withdrawn before infusion, with the amount based on the child's weight. Patients received Rocephin for infection prevention and pain relief with alternating doses of Ibuprofen and Efferalgan for 2 days post-procedure. Seduxen was given once on the first night after bone marrow collection.
RehabilitationOther
Rehabilitation methods involve various therapies tailored to the patient\'s mobility level. (1) Physical therapy focuses on exercises to control the head, neck, and trunk, manage muscle tone, and reduce spasticity. Patients gradually practice essential movements like rolling, sitting, crawling, standing, and walking, aligned with developmental milestones. (2) Occupational therapy aims to enhance fine motor skills and daily activities. Through hand function exercises, patients improve upper limb functionality, strengthen their ability to grasp and hold objects and refine coordination between both hands and hand-eye coordination. (3) Speech therapy improves communication, cognitive abilities, and chewing and swallowing functions. Specific exercises target lip and mouth movements, helping patients express and understand language better. Additionally, there are activities to strengthen jaw and facial muscles, which are essential for improving chewing and swallowing abilities.
| Study group | Role | What they receive |
|---|---|---|
| BM MNC transplantation and Rehabilitation | Active comparator | Patients in group A will receive two autologous BM MNC administrations at baseline and 6 months ± 21 days (T6) Receives: Biological: Autologous Bone Marrow Mononuclear Cell Transfusion; Other: Rehabilitation |
| Placebo with Rehabilitation, then BM MNC transplantation | Placebo comparator | Group B will receive BM MNCs at 9 months ± 21 days (T9) and 15 months ± 21 days (T15), with outcomes evaluated at 18 months ± 21 days (T18) compared to baseline. Receives: Biological: Autologous Bone Marrow Mononuclear Cell Transfusion; Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and Serious adverse events
The incidence of adverse events or serious adverse events following transplantation includes events leading to death, life-threatening events, events requiring hospitalization or prolonging hospital stay, events resulting in significant or permanent disability, and events causing birth defects in newborns.
Measured: Up to 9 months for Group A and 18 months for Group B during the study.
Gross Motor Function Measure-88 (GMFM-88)
Evaluate the effectiveness of umbilical cord blood stem cell transplantation in children with cerebral palsy based on changes in gross motor function score after the first cell transplantation.
Measured: Group A: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days)/ Group B: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days); 12 months (T12±21 days); 15 months (T15±21 days); 18 months (T18±21 days).
Gross Motor Function Classification System (GMFCS)
This tool will be used to classify the severity of motor function impairment in children with cerebral palsy.
Measured: Group A: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days). Group B: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days); 12 months (T12±21 days); 15 months (T15±21 days); 18 months (T18±21 days).
The Mini-Manual Ability Classification System (Mini-MACS) and Manual Ability Classification System (MACS)
Hand function after the first cell transplantation: Mini-MACS (Manual Ability Classification System) for children aged 1 to 4 years, and MACS for children aged over 4 to 18 years.
Measured: Group A: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days). Group B: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days); 12 months (T12±21 days); 15 months (T15±21 days); 18 months (T18±21 days).
Modified Ashworth Scale
Change in muscle tone after the first cell transplantation.
Measured: Group A: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days). Group B: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days); 12 months (T12±21 days); 15 months (T15±21 days); 18 months (T18±21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Oct 2024
- Primary completion15 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liem T Nguyen, MD., PhD, Principal investigator, Vinmec Research Insitute of Stem Cell and Gene Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629324
- Sponsor's protocol ID
- ISC-22.72
- Status last verified
- Jan 2026
- First submitted
- 3 Oct 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in the Treatment of Cerebral Palsy Due to Brain Hypoxia: A Phase II Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06629324
- Acronym / sponsor ID
- ISC-22.72
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene TechnologyUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to evaluate the effectiveness of autologous bone marrow mononuclear cell transfusion in treating cerebral palsy caused by cerebral hypoxia.
The key questions the study seeks to answer are:
- What is the safety profile in terms of adverse events (AE) and serious adverse events (SAE) observed over the 9 months following the first transplantation?
- How does autologous bone marrow mononuclear cell (BM MNC) transplantation impact the gross motor function (GMFM-88) scores and Gross Motor Function Classification System (GMFCS) scores in children with cerebral palsy?
- How does autologous BM MNC transplantation influence muscle tone (Modified Ashworth Scale score) and hand motor function (MACS/Mini-MACS scale) in children with cerebral palsy, 9 months post the initial transplantation?
Fifty-eight selected patients, aged 1 to 10 years and diagnosed with spastic cerebral palsy due to brain hypoxia, will be randomly divided into two groups:
- Group A: will receive two BM MNC infusions with the first at baseline and the second at 6 months ± 21 days (T6) via the spinal route.
- Group B: will serve as the control group for the first 9 months. During this period, patients will not receive cell transplantation but will undergo a similar rehabilitation and medication regimen as Group A. After 9 months, Group B will receive two BM MNC infusions: the first at 9 months ± 21 days (T9) and the second at 15 months ± 21 days (T15) via the spinal route, with a follow-up at 18 months ± 21 days (T18) compared to baseline.
- Both groups: will undergo rehabilitation for 10 days per month, three times, either at rehabilitation centers or performed by a rehabilitation technician at home. After this period, continued training will be conducted by family members. The combined medication regimen will include muscle relaxants (if muscle spasticity is present), vitamins, and neuroprotective drugs (Piracetam).
Detailed description
Cerebral Palsy (CP) is one of the most common causes of motor disability in children, significantly affecting their quality of life (QOL). Children with CP often face various challenges, including motor, sensory, and communication difficulties [1]. Recent studies suggest that autologous bone marrow-derived mononuclear cells (BM MNCs) show promise in improving motor function and reducing muscle spasticity in CP children [2, 3, 4]. The effects of BM MNC transplantation on the quality of life in CP children and their families remain understudied, despite improvements in motor function being reported.
Our Phase I study evaluated the safety and effects of autologous BM MNCs on the improvement of gross motor function and muscle tone in children with CP. This Phase II randomized clinical trial aims to evaluate the efficacy of autologous BM MNCs in children with CP at Vinmec International Hospital, Hanoi, Vietnam, from October 2024 to January 2027 [5]. The inclusion criteria are: (1) aged 1 to 10 years and of either sex; (2) having a Gross Motor Function Classification System (GMFCS) score ranging from level II to level V; and (3) spastic cerebral palsy due to cerebral hypoxia. Patients will be excluded if they have coagulation disorders; suffer from severe health conditions such as exhaustion, heart, lung, liver, or kidney failure, or active infections; have spinal injuries that prevent the administration of intrathecal injections; are diagnosed with cancer; test positive for HIV or have active viral hepatitis; or have hemoglobin levels below 110 g/L.
In total, 58 patients were randomly assigned to two groups. Randomization allocation was conducted using a random number table, and the ratio of participants in each group was 1:1. Group A will receive two BM MNC administrations: the first at baseline and the second at 6 months ± 21 days (T6) via intrathecal injection. Concomitantly, the CT group will undergo a 10-day-per-month rehabilitation program for 3 months, either at rehabilitation centers or with at-home therapy, followed by exercises managed by family members. Group B will serve as the control group for the first 9 months, receiving rehabilitation and medications similar to Group A but without BM MNC therapy. After 9 months, Group B will receive BM MNCs at 9 months ± 21 days (T9) and 15 months ± 21 days (T15), with outcomes evaluated at 18 months ± 21 days (T18) compared to baseline.
Bone marrow was collected under general anesthesia from both anterior superior iliac crests, taking 15-20 minutes, with a maximum volume of 350 mL for older children. Mononuclear cells were isolated using Ficoll density gradient centrifugation and prepared for infusion. The infusion, performed in the L4-L5 spinal space, lasted about 30 minutes at a rate of 20 mL per hour. Cerebrospinal fluid (CSF) was withdrawn before infusion, with the amount based on the child's weight. Patients received Rocephin for infection prevention and pain relief with alternating doses of Ibuprofen and Efferalgan for 2 days post-procedure. Seduxen was given once on the first night after bone marrow collection. The rehabilitation program included exercises for head and body control, muscle tone management, and facilitated movements based on developmental milestones. Occupational therapy focused on improving hand function and daily activities, while speech therapy addressed communication, comprehension, and chewing/swallowing abilities.
The safety of the therapy will be assessed by monitoring the frequency and severity of adverse events (AEs) and serious adverse events (SAEs). SAEs include events leading to death, life-threatening conditions, hospitalizations or prolonged hospital stays, significant or permanent disabilities, and congenital abnormalities or birth defects. Efficacy will be evaluated based on changes in gross motor function 9 months after the first BM MNC transplant. This will involve the GMFM-88 scale to assess gross motor function, the GMFCS scale to classify motor function severity, and the Mini-MACs (for children aged 1-4) and MACs (for children aged 4-18) scales to measure hand function. Additionally, muscle tone changes will be measured using the Modified Ashworth Scale 9 months post-transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BM MNC transplantation and Rehabilitation | Active comparator | Biological: Autologous Bone Marrow Mononuclear Cell Transfusion, Other: RehabilitationPatients in group A will receive two autologous BM MNC administrations at baseline and 6 months ± 21 days (T6) |
| Placebo with Rehabilitation, then BM MNC transplantation | Placebo comparator | Biological: Autologous Bone Marrow Mononuclear Cell Transfusion, Other: RehabilitationGroup B will receive BM MNCs at 9 months ± 21 days (T9) and 15 months ± 21 days (T15), with outcomes evaluated at 18 months ± 21 days (T18) compared to baseline. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from 1 to 10 years, both genders;
- Gross Motor Function Classification System (GMFCS): levels II to V;
- Spastic cerebral palsy due to brain hypoxia.
Key exclusion criteria (6 listed)
- Coagulation disorders;
- Severe health conditions such as cachexia, heart failure, lung, liver, or kidney failure; or active infections;
- Spinal injuries prevent the placement of a catheter through the spinal cavity;
- Cancer;
- HIV positive, active viral hepatitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Bone Marrow Mononuclear Cell TransfusionBone marrow was collected under general anesthesia from both anterior superior iliac crests, taking 15-20 minutes, with a maximum volume of 350 mL for older children. Mononuclear cells were isolated using Ficoll density gradient centrifugation and prepared for infusion. The infusion, performed in the L4-L5 spinal space, lasted about 30 minutes at a rate of 20 mL per hour. Cerebrospinal fluid (CSF) was withdrawn before infusion, with the amount based on the child's weight. Patients received Rocephin for infection prevention and pain relief with alternating doses of Ibuprofen and Efferalgan for 2 days post-procedure. Seduxen was given once on the first night after bone marrow collection. | Biological | BM MNC transplantation and Rehabilitation, Placebo with Rehabilitation, then BM MNC transplantation |
| RehabilitationRehabilitation methods involve various therapies tailored to the patient\'s mobility level. (1) Physical therapy focuses on exercises to control the head, neck, and trunk, manage muscle tone, and reduce spasticity. Patients gradually practice essential movements like rolling, sitting, crawling, standing, and walking, aligned with developmental milestones. (2) Occupational therapy aims to enhance fine motor skills and daily activities. Through hand function exercises, patients improve upper limb functionality, strengthen their ability to grasp and hold objects and refine coordination between both hands and hand-eye coordination. (3) Speech therapy improves communication, cognitive abilities, and chewing and swallowing functions. Specific exercises target lip and mouth movements, helping patients express and understand language better. Additionally, there are activities to strengthen jaw and facial muscles, which are essential for improving chewing and swallowing abilities. | Other | BM MNC transplantation and Rehabilitation, Placebo with Rehabilitation, then BM MNC transplantation |
Primary outcome
Adverse events and Serious adverse events
Time frame: Up to 9 months for Group A and 18 months for Group B during the study.
The incidence of adverse events or serious adverse events following transplantation includes events leading to death, life-threatening events, events requiring hospitalization or prolonging hospital stay, events resulting in significant or permanent disability, and events causing birth defects in newborns.
Gross Motor Function Measure-88 (GMFM-88)
Time frame: Group A: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days)/ Group B: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days); 12 months (T12±21 days); 15 months (T15±21 days); 18 months (T18±21 days).
Evaluate the effectiveness of umbilical cord blood stem cell transplantation in children with cerebral palsy based on changes in gross motor function score after the first cell transplantation.
Gross Motor Function Classification System (GMFCS)
Time frame: Group A: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days). Group B: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days); 12 months (T12±21 days); 15 months (T15±21 days); 18 months (T18±21 days).
This tool will be used to classify the severity of motor function impairment in children with cerebral palsy.
The Mini-Manual Ability Classification System (Mini-MACS) and Manual Ability Classification System (MACS)
Time frame: Group A: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days). Group B: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days); 12 months (T12±21 days); 15 months (T15±21 days); 18 months (T18±21 days).
Hand function after the first cell transplantation: Mini-MACS (Manual Ability Classification System) for children aged 1 to 4 years, and MACS for children aged over 4 to 18 years.
Modified Ashworth Scale
Time frame: Group A: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days). Group B: Baseline; 3 months (T3±21 days); 6 months (T6±21 days); 9 months (T9±21 days); 12 months (T12±21 days); 15 months (T15±21 days); 18 months (T18±21 days).
Change in muscle tone after the first cell transplantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liem T Nguyen, MD., PhD principal investigator
Vinmec Research Insitute of Stem Cell and Gene Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Bone Marrow Mononuclear Cell Transfusion and Rehabilitation in people with Autism Spectrum Disorder, run by Vinmec Research Institute of Stem Cell and Gene Technology at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liem T Nguyen, MD, PhD (800-555-5555, v.liemnt@vinmec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and Serious adverse events (time frame: Up to 9 months for Group A and 18 months for Group B during the study.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.