Autism Spectrum Disorders Clinical Trial
Official title:
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Autism Spectrum Disorders
| NCT number | NCT01974973 |
| Other study ID # | NGBSI-02 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | August 2009 |
| Est. completion date | May 2016 |
| Verified date | October 2018 |
| Source | Neurogen Brain and Spine Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with autism spectrum disorders
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | May 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Months to 40 Years |
| Eligibility |
Inclusion Criteria: - Diagnosed cases of any type of autism spectrum disorders - age above 6 months Exclusion Criteria: - presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus - malignancies - bleeding tendencies - pneumonia - renal failure - severe liver dysfunction - severe anemia [Hemoglobin < 8] - any bone marrow disorder - space occupying lesion in brain - other acute medical conditions such as respiratory infection and pyrexia |
| Country | Name | City | State |
|---|---|---|---|
| India | Neurogen brain and spine institute | Mumbai | Maharashtra |
| Lead Sponsor | Collaborator |
|---|---|
| Neurogen Brain and Spine Institute |
India,
Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in the scales for Autism spectrum disorders | Six months | ||
| Secondary | Positron Emission Tomography- computed tomography to study change in brain metabolism | six months |
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