Autistic DisorderNCT02168868
Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)
An observational study of Autistic Disorder, run by Benjamin Gesundheit at 1 site in Israel.
Trial summary
Behavioral testing is the gold standard for diagnosing autism spectrum disorder (ASD). These tests, including ADOS and ADI-R, are subjective, require trained staff to administer, are time-consuming, and can only be administered at a later age. Read more about this study
- Who is it for?
- Ages 10 months to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Blood draw, Stool Sample Collection and Urine Sample Collection
- Type of treatment
- Injection or infusion
- How many people
- 900 participants
- Where
- 1 siteIsrael
- Study dates
- May 2013to Dec 2030
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 10 months to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 1. Up to a total of 350 male and female children, aged 2-12 years, diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) 2. Up to a total of 350 male and female typically developing (TD) children aged 2-12 years with no signs of ASD or history of ASD in the immediate family who will serve as controls for the main subset of children with ASD 3. Up to 50 infants aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) (herein, high-risk infants) 4. Up to 50 mothers of the high-risk infants participating in the study 5. Up to 50 male and female children, aged 2-12 years, diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) scheduled to undergo stem cell therapy (SCT) 6. Up to 50 male and female children, aged 12-18 years, diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) scheduled to undergo SCT
Who may be able to join
- Male and female children
- Child aged 2-12 years with diagnosed ASD according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (299.00) or DSM-V (299.00) OR Child aged 2-18 years diagnosed ASD according to DSM-IV (299.00) or DSM-V (299.00) AND scheduled to undergo stem cell transplantation OR Child aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD according to (DSM)-IV (299.00) or DSM-V (299.00) (herein termed "high-risk infants") OR Mothers of recruited high-risk infants OR A typically developing child aged 2-12 years with no signs of ASD or history of ASD in the immediate family
- Informed consent signed by the parent/legal guardian
Who cannot join
- Child and/or mother completed treatment with systemic steroids or immune suppressants less than 4 weeks before the screening visit
- Child and/or mother diagnosed with severe infectious diseases or sepsis over the last 6 months
- Child with ASD treated for a severe convulsive disorder (intractable seizures)
- Child and/or mother with hematological or malignant disorder
- For children in the SCT cohort: No new planned immune-modulating treatment (other than SCT) for at least 6 months before or after planned stem cell transplantation date
- If the PI suspects that the participant will not comply with study requirements, the participant may be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Benjamin Gesundheit, M.D. contact
Leah Hochbaum contact
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 91031
Avraham Steinberg, MD, avraham@steinberg.onmicrosoft.com
Avraham Steinberg, MD
About this study
Behavioral testing is the gold standard for diagnosing autism spectrum disorder (ASD). These tests, including ADOS and ADI-R, are subjective, require trained staff to administer, are time-consuming, and can only be administered at a later age. Blood-, urine- or stool-based diagnostic biomarker test for ASD would enable objective early diagnosis, potentially even before clinical symptoms are present, eliminate the need for trained staff and enable early intervention. Such a test would not only conserve money and time but would also provide clues to ASD pathogenesis.
To date, no definitive treatment exists for ASD. Most therapies are symptom-focused, generally focusing on behavioral, social and communication skills. Recent works have reported on promising outcomes of mesenchymal stem cell (MSC) treatment of children with ASD. MSCs are multipotent, non-hematopoietic, easily isolatable and expandable stem cells involved in tissue repair, immunomodulatory responses and neuromodulation. MSC treatment of children with ASD has reportedly led to improvements in speech, sociability, eye coordination, balance, cognition and overall well-being. At the base of this approach lies the known plasticity of the human brain and immune system in the early childhood years and the ability of MSCs to modulate atypical inflammatory and immune activities. Assessment of ASD biomarker profiles in children with ASD who have undergone one or more SCT sessions may shed light on the mechanism of action, assist in better defining ASD-specific diagnostic markers and monitor treatment outcomes.
Read the detailed description
There is accumulating evidence that at least a subset of children diagnosed with ASD also have aberrant immune functions. This study will attempt to identify more specifically the nature of the potential immune abnormalities in children.
The study will follow a case-control design, involving the following cohorts:
- young children (2-12 years) diagnosed with ASD
- children (12-18 years) diagnosed with ASD
- age- and sex-matched typically developing children
- high-risk infants (10-19 months) with at least one sibling with diagnosed ASD
- mothers of these high-risk infants
- young children (2-12 years) diagnosed with ASD and scheduled to undergo stem cell transplantation therapy (SCT)
Parents will be asked to complete several questionnaires relating to demographic and anamnestic details and to the child's development.
- A single blood draw from all participants will be performed in the clinic.
- A stool sample will be collected from high-risk infants.
- A stool and urine sample will be collected at home from children due to undergo SCT. For children scheduled to undergo SCT, the blood, stool and urine samples must be collected before therapy.
- Parents of high-risk infants will be contacted by phone or email when the child reaches diagnosable age (3.5 years) and again at the age of 6 years, to obtain an update on the child's ASD status. If the child has been diagnosed with ASD, an additional blood and stool sample may be collected.
- Children who underwent SCT will be contacted 2±1 months and 6±1 months after the first treatment session, for collection of additional blood samples. Stool and urine samples will be collected at the 6±1 month post-treatment visit as well. Should the child undergo additional SCT within two years of the first treatment, additional blood, stool and urine samples may be collected. At each subsequent visit, a parent/legal guardian will be asked to complete several short questionnaires.
Adverse events to blood drawing will be reported to the Data Coordinating Center using the appropriate Case Report Form (CRF).
In cases of adverse effects (AE) related to the drawing of blood or performance of examination of patients in the course of standard examination procedures, the investigating team will proceed in accordance with local guidelines (to be inserted by the PI), reporting the incidents which occurred during the course of a clinical trial.
Clinical data will be collected by the investigator, or a person appointed and appropriately trained by the investigator, and shall be entered into standardized CRFs and shared online with the sponsor. Source data will be retained for all data entered in the CRFs. Progress reports and the Final Report at the conclusion of the trial will be submitted to the regulatory authority and the Ethics Committee, as required.
- Conditions
- Autistic Disorder
- Being tested
- Blood draw, Stool Sample Collection, Urine Sample Collection
- Keywords
- Autoimmune Diseases, Child Development Disorders, Inflammation, Risk Factors, Pervasive, Autism, Autistic Disorder
- Medical subject headings
- Autistic Disorder, Autoimmune Diseases, Developmental Disabilities, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawDiagnostic test
Also called blood sample, venepuncture
A blood sample (5 mL) will be collected.
Stool Sample CollectionDiagnostic test
Also called Stool Analysis
Subjects will be provided a dry, plastic, screw-top specimen container and will be asked to collect a stool sample at home.
Urine Sample CollectionDiagnostic test
Also called Urinalysis
Subjects will be provided a dry, plastic, screw-top specimen container and will be asked to collect a urine sample at home.
| Study group | Role | What they receive |
|---|---|---|
| Control Group of Young Children | 2-12 years old age \& sex-matched controls - typically developing (TD) children Receives: Diagnostic Test: Blood draw | |
| Young Children-Autism Spectrum Disorder | 2-12 years old children diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) Receives: Diagnostic Test: Blood draw | |
| Young Children-Autism Spectrum Disorder+SCT | 2-12 years old children diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) due to undergo stem cell transplantation therapy Receives: Diagnostic Test: Blood draw; Diagnostic Test: Stool Sample Collection; Diagnostic Test: Urine Sample Collection | |
| High-risk infants | Infants aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD Receives: Diagnostic Test: Blood draw; Diagnostic Test: Stool Sample Collection | |
| Mothers of high-risk infants | Mothers of recruited infants aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD Receives: Diagnostic Test: Blood draw | |
| Adolescent-Autism Spectrum Disorder+SCT | 12-18 years old children diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) due to undergo stem cell transplantation therapy Receives: Diagnostic Test: Blood draw; Diagnostic Test: Stool Sample Collection; Diagnostic Test: Urine Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of discriminating proteomic biomarker profile in blood of children with ASD vs. matched TD children
Finding a proteomic signature in children with ASD
Measured: One day
Identification of discriminating proteomic biomarker profiles in blood of high-risk infants, at recruitment vs. after diagnosis of ASD, if diagnosed
Finding a proteomic signature in infants at high-risk of ASD
Measured: Up to 5 years after initial blood draw
Comparison of blood biomarker profiles in ASD children before versus after SCT
Finding ASD-specific blood proteomic biomarkers that can be modified by SCT
Measured: Through study completion, up to 6 months
Secondary outcomes (2)
ASD severity vs. blood biomarker levels
Correlative assessment of ASD severity vs. blood biomarker levels
Measured: Through study, up to 5 years, depending on cohort
Blood biomarker levels and SCT outcomes
Correlative assessment of blood biomarker levels and SCT outcomes
Measured: Through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startMay 2013
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autistic 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Benjamin Gesundheit
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shaare Zedek Medical Center
- Responsible party
- Sponsor-investigator, Benjamin Gesundheit, Cell El Ltd
- Investigators
- Benjamin Gesundheit, MD, Principal investigator, Cell El Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168868
- Sponsor's protocol ID
- CellEL-920130030
- Status last verified
- Feb 2023
- First submitted
- 19 Jun 2014
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gesundheit B, Rosenzweig JP, Naor D, Lerer B, Zachor DA, Prochazka V, Melamed M, Kristt DA, Steinberg A, Shulman C, Hwang P, Koren G, Walfisch A, Passweg JR, Snowden JA, Tamouza R, Leboyer M, Farge-Bancel D, Ashwood P. Immunological and autoimmune considerations of Autism Spectrum Disorders. J Autoimmun. 2013 Aug;44:1-7. doi: 10.1016/j.jaut.2013.05.005. Epub 2013 Jul 15.
PubMed 23867105Gesundheit B, Zisman PD, Hochbaum L, Posen Y, Steinberg A, Friedman G, Ravkin HD, Rubin E, Faktor O, Ellis R. Autism spectrum disorder diagnosis using a new panel of immune- and inflammatory-related serum biomarkers: A case-control multicenter study. Front Pediatr. 2023 Feb 21;11:967954. doi: 10.3389/fped.2023.967954. eCollection 2023.
PubMed 36896401
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT02168868
- Acronym / sponsor ID
- CellEL-920130030
- Conditions
- Autistic Disorder
- Keywords
- Autoimmune Diseases, Child Development Disorders, Inflammation, Risk Factors, Pervasive, Autism, Autistic Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Benjamin GesundheitIndustry (pharma, biotech, devices)
- Collaborators
- Shaare Zedek Medical Center
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Jun 2014 (estimated)
- 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.
Behavioral testing is the gold standard for diagnosing autism spectrum disorder (ASD). These tests, including ADOS and ADI-R, are subjective, require trained staff to administer, are time-consuming, and can only be administered at a later age. Blood-, urine- or stool-based diagnostic biomarker test for ASD would enable objective early diagnosis, potentially even before clinical symptoms are present, eliminate the need for trained staff and enable early intervention. Such a test would not only conserve money and time but would also provide clues to ASD pathogenesis.
To date, no definitive treatment exists for ASD. Most therapies are symptom-focused, generally focusing on behavioral, social and communication skills. Recent works have reported on promising outcomes of mesenchymal stem cell (MSC) treatment of children with ASD. MSCs are multipotent, non-hematopoietic, easily isolatable and expandable stem cells involved in tissue repair, immunomodulatory responses and neuromodulation. MSC treatment of children with ASD has reportedly led to improvements in speech, sociability, eye coordination, balance, cognition and overall well-being. At the base of this approach lies the known plasticity of the human brain and immune system in the early childhood years and the ability of MSCs to modulate atypical inflammatory and immune activities. Assessment of ASD biomarker profiles in children with ASD who have undergone one or more SCT sessions may shed light on the mechanism of action, assist in better defining ASD-specific diagnostic markers and monitor treatment outcomes.
Detailed description
There is accumulating evidence that at least a subset of children diagnosed with ASD also have aberrant immune functions. This study will attempt to identify more specifically the nature of the potential immune abnormalities in children.
The study will follow a case-control design, involving the following cohorts:
- young children (2-12 years) diagnosed with ASD
- children (12-18 years) diagnosed with ASD
- age- and sex-matched typically developing children
- high-risk infants (10-19 months) with at least one sibling with diagnosed ASD
- mothers of these high-risk infants
- young children (2-12 years) diagnosed with ASD and scheduled to undergo stem cell transplantation therapy (SCT)
Parents will be asked to complete several questionnaires relating to demographic and anamnestic details and to the child's development.
- A single blood draw from all participants will be performed in the clinic.
- A stool sample will be collected from high-risk infants.
- A stool and urine sample will be collected at home from children due to undergo SCT. For children scheduled to undergo SCT, the blood, stool and urine samples must be collected before therapy.
- Parents of high-risk infants will be contacted by phone or email when the child reaches diagnosable age (3.5 years) and again at the age of 6 years, to obtain an update on the child's ASD status. If the child has been diagnosed with ASD, an additional blood and stool sample may be collected.
- Children who underwent SCT will be contacted 2±1 months and 6±1 months after the first treatment session, for collection of additional blood samples. Stool and urine samples will be collected at the 6±1 month post-treatment visit as well. Should the child undergo additional SCT within two years of the first treatment, additional blood, stool and urine samples may be collected. At each subsequent visit, a parent/legal guardian will be asked to complete several short questionnaires.
Adverse events to blood drawing will be reported to the Data Coordinating Center using the appropriate Case Report Form (CRF).
In cases of adverse effects (AE) related to the drawing of blood or performance of examination of patients in the course of standard examination procedures, the investigating team will proceed in accordance with local guidelines (to be inserted by the PI), reporting the incidents which occurred during the course of a clinical trial.
Clinical data will be collected by the investigator, or a person appointed and appropriately trained by the investigator, and shall be entered into standardized CRFs and shared online with the sponsor. Source data will be retained for all data entered in the CRFs. Progress reports and the Final Report at the conclusion of the trial will be submitted to the regulatory authority and the Ethics Committee, as required.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control Group of Young Children | – | Diagnostic Test: Blood draw2-12 years old age \& sex-matched controls - typically developing (TD) children |
| Young Children-Autism Spectrum Disorder | – | Diagnostic Test: Blood draw2-12 years old children diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) |
| Young Children-Autism Spectrum Disorder+SCT | – | Diagnostic Test: Blood draw, Diagnostic Test: Stool Sample Collection, Diagnostic Test: Urine Sample Collection2-12 years old children diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) due to undergo stem cell transplantation therapy |
| High-risk infants | – | Diagnostic Test: Blood draw, Diagnostic Test: Stool Sample CollectionInfants aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD |
| Mothers of high-risk infants | – | Diagnostic Test: Blood drawMothers of recruited infants aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD |
| Adolescent-Autism Spectrum Disorder+SCT | – | Diagnostic Test: Blood draw, Diagnostic Test: Stool Sample Collection, Diagnostic Test: Urine Sample Collection12-18 years old children diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) due to undergo stem cell transplantation therapy |
Who may qualify
- Ages
- 10 months to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 1. Up to a total of 350 male and female children, aged 2-12 years, diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) 2. Up to a total of 350 male and female typically developing (TD) children aged 2-12 years with no signs of ASD or history of ASD in the immediate family who will serve as controls for the main subset of children with ASD 3. Up to 50 infants aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) (herein, high-risk infants) 4. Up to 50 mothers of the high-risk infants participating in the study 5. Up to 50 male and female children, aged 2-12 years, diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) scheduled to undergo stem cell therapy (SCT) 6. Up to 50 male and female children, aged 12-18 years, diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00) scheduled to undergo SCT
Key inclusion criteria (3 listed)
- Male and female children
- Child aged 2-12 years with diagnosed ASD according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (299.00) or DSM-V (299.00) OR Child aged 2-18 years diagnosed ASD according to DSM-IV (299.00) or DSM-V (299.00) AND scheduled to undergo stem cell transplantation OR Child aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD according to (DSM)-IV (299.00) or DSM-V (299.00) (herein termed "high-risk infants") OR Mothers of recruited high-risk infants OR A typically developing child aged 2-12 years with no signs of ASD or history of ASD in the immediate family
- Informed consent signed by the parent/legal guardian
Key exclusion criteria (6 listed)
- Child and/or mother completed treatment with systemic steroids or immune suppressants less than 4 weeks before the screening visit
- Child and/or mother diagnosed with severe infectious diseases or sepsis over the last 6 months
- Child with ASD treated for a severe convulsive disorder (intractable seizures)
- Child and/or mother with hematological or malignant disorder
- For children in the SCT cohort: No new planned immune-modulating treatment (other than SCT) for at least 6 months before or after planned stem cell transplantation date
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 |
|---|---|---|
| Blood drawAlso: blood sample, venepunctureA blood sample (5 mL) will be collected. | Diagnostic test | Adolescent-Autism Spectrum Disorder+SCT, Control Group of Young Children, High-risk infants, Mothers of high-risk infants, Young Children-Autism Spectrum Disorder, Young Children-Autism Spectrum Disorder+SCT |
| Stool Sample CollectionAlso: Stool AnalysisSubjects will be provided a dry, plastic, screw-top specimen container and will be asked to collect a stool sample at home. | Diagnostic test | Adolescent-Autism Spectrum Disorder+SCT, High-risk infants, Young Children-Autism Spectrum Disorder+SCT |
| Urine Sample CollectionAlso: UrinalysisSubjects will be provided a dry, plastic, screw-top specimen container and will be asked to collect a urine sample at home. | Diagnostic test | Adolescent-Autism Spectrum Disorder+SCT, Young Children-Autism Spectrum Disorder+SCT |
Primary outcome
Identification of discriminating proteomic biomarker profile in blood of children with ASD vs. matched TD children
Time frame: One day
Finding a proteomic signature in children with ASD
Identification of discriminating proteomic biomarker profiles in blood of high-risk infants, at recruitment vs. after diagnosis of ASD, if diagnosed
Time frame: Up to 5 years after initial blood draw
Finding a proteomic signature in infants at high-risk of ASD
Comparison of blood biomarker profiles in ASD children before versus after SCT
Time frame: Through study completion, up to 6 months
Finding ASD-specific blood proteomic biomarkers that can be modified by SCT
2 secondary outcomes
ASD severity vs. blood biomarker levels
Time frame: Through study, up to 5 years, depending on cohort
Blood biomarker levels and SCT outcomes
Time frame: Through study completion, up to 6 months
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 25 Nov 2024.
- Background: PubMed 23867105Gesundheit B, Rosenzweig JP, Naor D, Lerer B, Zachor DA, Prochazka V, Melamed M, Kristt DA, Steinberg A, Shulman C, Hwang P, Koren G, Walfisch A, Passweg JR, Snowden JA, Tamouza R, Leboyer M, Farge-Bancel D, Ashwood P. Immunological and autoimmune considerations of Autism Spectrum Disorders. J Autoimmun. 2013 Aug;44:1-7. doi: 10.1016/j.jaut.2013.05.005. Epub 2013 Jul 15.
- Background: PubMed 36896401Gesundheit B, Zisman PD, Hochbaum L, Posen Y, Steinberg A, Friedman G, Ravkin HD, Rubin E, Faktor O, Ellis R. Autism spectrum disorder diagnosis using a new panel of immune- and inflammatory-related serum biomarkers: A case-control multicenter study. Front Pediatr. 2023 Feb 21;11:967954. doi: 10.3389/fped.2023.967954. eCollection 2023.
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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.
Benjamin Gesundheit, M.D. contact
Leah Hochbaum contact
Benjamin Gesundheit, MD principal investigator
Cell El Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorder, run by Benjamin Gesundheit at 1 site in Israel.
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 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Benjamin Gesundheit, M.D. (gesundheitmd@cell-el.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of discriminating proteomic biomarker profile in blood of children with ASD vs. matched TD children (time frame: One day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02168868, which also lists 2 linked publications.
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 25 Nov 2024.