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Neurogen Brain and Spine Institute, is conducting a clinical trial with an aim to study the effect of autologous bone marrow stem cell therapy on
common symptoms in patients with autism spectrum disorders (ASD).
It is a single arm, open-label, self funded (patients' own funding) clinical trial. The objective of the study was to evaluate the efficacy of the
intervention on symptoms of ASD. This trial is registered on clinicaltrial.gov (ClinicalTrials.gov Identifier: NCT01974973)
Estimated Enrollment: 150 patients
Study Start Date: August 2009
Estimated Study Completion Date: October 2014
Status: Currently Recruiting
Site: Mumbai, India
About the intervention
Autologous bone marrow stem cell therapy
Stem cell therapy is done in three stages on the same day as follows:
1) Patient's bone marrow is aspirated under local anesthesia/sedation in the Operation theatre.
2) Separation of the stem cells (mononuclear cells) from the bone marrow is carried out in the laboratory.
3) Injection of these separated stem cells (patient's own) into the spinal fluid is done via a lumbar puncture under local anesthesia/sedation in the
Stem cell therapy is combined with NeuroRehabilitation which includes behavior therapy, occupational therapy, speech therapy, patient counseling,
family counseling, physiotherapy and other required rehabilitation.
Scientific basis of the trial
Recently, stem cell therapy has gained a lot of potential as a treatment for various disorders including autism. Stem cells carry out the repair of the
damaged tissues through various underlying mechanisms such as self renewal, transdifferentiation, paracrine effects, etc. When these cells are
administered, they migrate to the damaged areas. This property is known as 'homing'. Once they reach these areas, they stimulate the local cells to
promote repair. They are also known to form new blood vessels which improve the blood circulation in the brain along with increased oxygen supply.
They are also known to reduce the inflammation in the brain.
In this trial, autologous bone marrow derived mononuclear cells (BMMNCs) are being used as they are easy to obtain and do not involve any ethical or
moral issues. Autologous cells do not involve risk of immune rejection or any graft versus host disease (GVHD). BMMNCs are a mixture of diverse
population of cells. Hence, the effect exerted by whole BMMNCs is better than individual cells.
The route of administration used in this study is intrathecal (into the spinal fluid) as it is relatively less invasive and safe. These cells when injected
travel through the CSF to the affected areas in the brain.
Various studies have demonstrated the importance of exercise in activation of stem cells. In this trial, stem cell therapy is followed by rehabilitation
which includes behavior therapy, occupational therapy, psychological therapy and physiotherapy. Experts design a personalized rehabilitation program
for every individual patient. Rehabilitation augments the effect of stem cell therapy in autism.
Changes in the following parameters are recorded objectively pre and 6 months post intervention.
Primary outcome measures
1. Indian Scale for Assessment of Autism (ISAA)
2. Childhood Autism Rating Scale (CARS)
3. Clinical Global Impression (CGI)
Secondary outcome measures
Positron Emission Tomography- computed tomography (PET-CT) scan is used to study changes in brain metabolism.
It is a self funded clinical trial. The expenses of the trial are to be borne by the patient. No incentives such as travel allowance or living expenses will be
allocated. For more details about expenses contact email@example.com
About the trial