AutismPhase 1/2NCT01502488
Adipose Derived Stem Cell Therapy for Autism
A Phase 1/2 study testing Fat Harvesting and Stem Cell Injection in people with Autism, run by Ageless Regenerative Institute at 1 site in United States.
Trial summary
The intent of this clinical study is to answer the questions: 1. Is the proposed treatment safe 2. Is treatment effective in improving the disease pathology of patients with Autism. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism
- What is being tested?
- Fat Harvesting and Stem Cell Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jan 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 3 and 12 years.
- DSM-IV diagnosis of Autistic Disorder.
- Total score of CARS ≥ 30.
- Parents or legal guardian willing to sign the ICF.
Who cannot join
- History of prior or current DSM-IV psychotic disorder (e.g., schizophrenia, bipolar disorder, other psychosis), Pervasive Developmental Disorder not otherwise specified (PDD NOS), Asperger's, or Rett's.
- History of Epileptic seizure activity in the past 6 months.
- Autism caused by seizure disorders (active), cerebrovascular disease or brain trauma.
- The global autism ratings are assessed as being absent, minimal or mild.
- Existing moderate or severe extrapyramidal symptoms (EPS) or history of tardive dyskinesia.
- Active infectious disease and/or known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have expert consultation to determine eligibility based on the patient's infectious status
Show all 14Show fewer
- Enrollment in other trials in the last 3 months without agreement to discontinue them.
- Life expectancy < 6 months due to concomitant illnesses.
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- Patients on chronic immunosuppressive transplant therapy
- Active clinical infection within one week of enrollment.
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- History of cancer
- Parental unwillingness and/or not able to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ageless Regenerative Institute LLC
Aventura, Florida, 33180
About this study
Official title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Autism
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Autism.
Read the detailed description
This will be an open-label, non-randomized multi-center patient sponsored study of ASC implantation after liposuction using an IV delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered intravenously.
- Conditions
- Autism
- Being tested
- Fat Harvesting and Stem Cell Injection
- Keywords
- Autistic, ASC therapy, ADSC
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat Harvesting and Stem Cell InjectionProcedure or surgery
Also called Liposuction, Adipose Derived Stem Cell Injection, ADSC, Lipo
Cells will be harvested through a local liposuction and injected via IV delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the Childhood Autism Rating Scale，CARS
Measured: 3 months
Improvement in the Clinical Global Impression Scale, CGI
Measured: 3 months
Improvement in the Childhood Autism Rating Scale，CARS
Measured: 6 months
Improvement in the Clinical Global Impression Scale, CGI
Measured: 6 months
Secondary outcomes (2)
Improvement in the Aberrant Behavior Checklist, ABC
Measured: 3 months
Improvement in the Aberrant Behavior Checklist, ABC
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startOct 2016
- Primary completionNov 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ageless Regenerative Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto de Medicina Regenerativa
- Responsible party
- Sponsor
- Investigators
- Sharon McQuillan, MD, Principal investigator, Ageless Regenerative Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502488
- Sponsor's protocol ID
- ADI-AT-001
- Status last verified
- Jul 2017
- First submitted
- 27 Dec 2011
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Autism
- ClinicalTrials.gov ID
- NCT01502488
- Acronym / sponsor ID
- ADI-AT-001
- Conditions
- Autism
- Keywords
- Autistic, ASC therapy, ADSC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Instituto de Medicina Regenerativa
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 30 Dec 2011 (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.
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the disease pathology of patients with Autism.
Detailed description
This will be an open-label, non-randomized multi-center patient sponsored study of ASC implantation after liposuction using an IV delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between the ages of 3 and 12 years.
- DSM-IV diagnosis of Autistic Disorder.
- Total score of CARS ≥ 30.
- Parents or legal guardian willing to sign the ICF.
Key exclusion criteria (14 listed)
- History of prior or current DSM-IV psychotic disorder (e.g., schizophrenia, bipolar disorder, other psychosis), Pervasive Developmental Disorder not otherwise specified (PDD NOS), Asperger's, or Rett's.
- History of Epileptic seizure activity in the past 6 months.
- Autism caused by seizure disorders (active), cerebrovascular disease or brain trauma.
- The global autism ratings are assessed as being absent, minimal or mild.
- Existing moderate or severe extrapyramidal symptoms (EPS) or history of tardive dyskinesia.
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 |
|---|---|---|
| Fat Harvesting and Stem Cell InjectionAlso: Liposuction, Adipose Derived Stem Cell Injection, ADSC, LipoCells will be harvested through a local liposuction and injected via IV delivery | Procedure or surgery | – |
Primary outcome
Improvement in the Childhood Autism Rating Scale，CARS
Time frame: 3 months
Improvement in the Clinical Global Impression Scale, CGI
Time frame: 3 months
Improvement in the Childhood Autism Rating Scale，CARS
Time frame: 6 months
Improvement in the Clinical Global Impression Scale, CGI
Time frame: 6 months
2 secondary outcomes
Improvement in the Aberrant Behavior Checklist, ABC
Time frame: 3 months
Improvement in the Aberrant Behavior Checklist, ABC
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Sharon McQuillan, MD principal investigator
Ageless Regenerative Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fat Harvesting and Stem Cell Injection in people with Autism, run by Ageless Regenerative Institute at 1 site in United States.
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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 21 Jul 2017. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the Childhood Autism Rating Scale，CARS (time frame: 3 months). The study lists 4 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 21 Jul 2017; AzTrials last refreshed its copy on 28 Oct 2026.