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AutismPhase 1/2NCT01343511

Safety and Efficacy of Stem Cell Therapy in Patients With Autism

A Phase 1/2 study testing human cord blood mononuclear cells and human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells in people with Autism, run by Shenzhen Beike Bio-Technology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress .Neural hypoperfusion and immune… Read more about this study

Who is it for?
Ages 3 to 12 years
Conditions the study is for
Autism
What is being tested?
human cord blood mononuclear cells and human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
Mar 2009to May 2011
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

  • Any history of hypersensitivity to serum products, or other known drug and food allergy.
  • 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.
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  • Subjects who have displayed significant self-injurious behavior (children who have caused visible harm to themselves).
  • HIV+
  • Acute and chronic hepatitis.
  • Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
  • Severe pulmonary and hematological disease, malignancy or hypo-immunity.
  • Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
  • Enrollment in other trials in the last 3 months.
  • Other criteria the investigator consider improper for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shandong Jiaotong Hospital

    Jinan, Shandong, 250031

Other trials in China

About this study

Official title: Phase Ι/Π Study of Stem Cell Therapy in Patients With Autism

Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress .Neural hypoperfusion and immune deregulation are the two key pathologies associated with Autism. Human umbilical cord mesenchymal stem cells (hUC-MSCs) and human cord blood mononuclear cells (hCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUC-MSCs and hCB-MNCs transplantation will be evaluated in patients with Autism.

Read the detailed description

To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Autism.

Conditions
Autism
Being tested
human cord blood mononuclear cells, human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Keywords
Autism, human cord blood mononuclear cells, human umbilical cord mesenchymal stem cells
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • human cord blood mononuclear cellsBiological

    Also called Group 1

    Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.

  • human cord blood mononuclear cells and human umbilical cord mesenchymal stem cellsBiological

    Also called Group 2

    Participants will be given rehabilitation therapy plus and hCB-MNCs and hUC-MSCs transplantation.

Study groups in NCT01343511
Study groupRoleWhat they receive
Rehabilitation plus hCB-MNCs treatmentExperimentalParticipants will be given rehabilitation therapy plus human cord blood mononuclear cells transplantation with a 6 months follow-up.
Receives: Biological: human cord blood mononuclear cells
Rehabilitation plus hCB-MNCs and hUC-MSCs therapyExperimentalParticipants will be given rehabilitation therapy plus combination of hCB-MNCs together with hUC-MSCs transplantation with a 6 months follow-up.
Receives: Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Childhood Autism Rating Scale，CARS

    Measured: 6 months after treatment

  2. Clinical Global Impression Scale，CGI

    Measured: 6 months after treatment

Secondary outcomes (2)

  1. Aberrant Behavior Checklist，ABC

    Measured: 6 months after treatment

  2. Adverse Event and Serious Adverse Event

    Measured: 6 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2011 (estimated)
  2. Study startMar 2009
  3. Primary completionJun 2010
  4. Study completionMay 2011

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01343511
Sponsor's protocol ID
BKCR-AUTISM-1.0(2009)
Status last verified
Oct 2011
First submitted
26 Apr 2011
Last updated
14 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Liu M, Sun LW, LV YT, Huan Y, Ge RC, Cao YL, Guo CQ, Chen XW. Stem cells for treatment of autism: Safety and efficacy. Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu. 2010;14(32): 5967-5970.

  • Lv YT, Zhang Y, Liu M, Qiuwaxi JN, Ashwood P, Cho SC, Huan Y, Ge RC, Chen XW, Wang ZJ, Kim BJ, Hu X. Transplantation of human cord blood mononuclear cells and umbilical cord-derived mesenchymal stem cells in autism. J Transl Med. 2013 Aug 27;11:196. doi: 10.1186/1479-5876-11-196.

    PubMed 23978163

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing human cord blood mononuclear cells and human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells in people with Autism, run by Shenzhen Beike Bio-Technology Co., Ltd. at 1 site in China.

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: finished, as of the sponsor's last update on 14 Oct 2011. 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 China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Childhood Autism Rating Scale，CARS (time frame: 6 months after treatment). The study lists 2 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 NCT01343511, 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 14 Oct 2011.

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