Autism Term

Informed Consent Form

Treatment of Autism Spectrum Disorder Using a Regenerative Medicine Approach and Peptide Therapy

Dr. Ehsan Sotoudeh | General Surgeon and Regenerative Medicine Specialist | 2026

Dr. Ehsan Sotoudeh — Dubai, United Arab Emirates

Section one: Scope of Specialty and Services Provided

Important Notice: Please read this section carefully.

I, Dr. Ehsan Sotoudeh, am a general surgeon and specialist in regenerative medicine. My approach to the treatment of Autism Spectrum Disorder is entirely biological and based on regenerative medicine — not psychiatric or neurological treatment.

The following matters are explicitly outside the scope of my services:

1. I am not a psychiatrist or neurologist and do not provide psychiatric or neurological evaluation. 2. Diagnosis of Autism Spectrum Disorder, determination of severity level, whether Level 1, 2, or 3, and formal cognitive assessment are not within my area of specialty.
2. I do not provide consultation regarding conventional psychiatric medications such as aripiprazole, risperidone, methylphenidate, or similar medications.
3. I am not able to issue pharmacy prescriptions or medical certificates related to psychiatric medications.

Critical Warning — Psychiatric Medications:

Under no circumstances should the psychiatric medications prescribed by your child’s psychiatrist or neurologist be stopped, changed, or reduced without coordination with the prescribing physician. Doing so may result in serious and potentially irreversible risks.

Section two: FDA Approval Status and Regulatory Status

1. A) Licensing and Regulatory Status

Some of the prescribed treatment protocols are provided within an off-label and research-based framework and are not approved by any regulatory authority specifically for the indication of autism.

The use of off-label treatments is common in modern medicine and does not necessarily mean that there is no scientific evidence. However, the family must be fully aware of this status and must provide consent with complete understanding.

1. B) FDA Approval Status of Peptides
2. Some peptides used in medical practice have FDA approval for specific indications.
3. Most prescribed peptides do not currently have FDA approval for the treatment of autism and may be prescribed within an off-label or research-based protocol.
4. The FDA has scheduled a meeting in July 2026 to review the approval pathway for certain peptides.
5. The legal guardian confirms that they have been fully informed of the FDA approval status of each peptide and consent with full understanding.

Section Three: Nature of Treatment, Safety Warnings, and Protocol Changes A) Critical Drug Interaction Warning

Emergency Warning — Serotonin Syndrome:

If your child is currently taking aripiprazole, also known as Abilify, or any other antipsychotic medication, Methylene Blue must not be prescribed at the same time.

The interaction between these medications may lead to serotonin syndrome, which is a serious medical emergency.

Discontinuation of aripiprazole must only be done under the supervision of the prescribing psychiatrist and through gradual dose reduction.

1. B) Injectable Protocol and Monthly Adjustments
2. A major part of the treatment protocol may include subcutaneous injectable medications. Proper injection training will be provided by the medical team.
3. The monthly treatment protocol may change based on clinical response, laboratory results, and the patient’s progress.
4. The minimum expected time to observe the first significant clinical response is five months.
5. In some patients, especially during the early stages of treatment with folinic acid, also known as Leucovorin, a temporary worsening of behavioral symptoms may be observed. This phenomenon is usually transient and typically resolves within 2 to 9 weeks.
6. There is no guarantee of treatment response. Results vary among patients.

Section four: Medication Supply, Costs, and Responsibilities

1. A) Medical Prescription and Medication Supply

The legal guardian is fully aware of the following:

1. Dr. Ehsan Sotoudeh issues medical prescriptions for the prescribed peptides so that the family can obtain the medications from reliable sources.
2. The consultation fee for patients outside Iran is AED 1,000 (approximately USD 275) for a 45-minute session.
3. The autism consultation fee for residents of Iran is 10,000,000 Toman for a 45-minute session.
4. If needed, Dr. Sotoudeh may assist the family in obtaining the prescribed peptides from reliable sources. This may include issuing medical prescriptions and providing guidance regarding online ordering or obtaining the medications from reputable pharmacies in the United Arab Emirates.
5. The purchase, supply, and physical shipment of the medications are the responsibility of the family. Dr. Sotoudeh has no obligation to directly supply or ship the medications.
6. Proper storage of the medications, including appropriate temperature and expiration date control, is the responsibility of the family.
7. B) Estimated Costs

Section Five: Questionnaires, Baseline Assessment, and Research Consent

The legal guardian agrees and undertakes to:

1. Complete the required baseline assessment before starting treatment. The results of the questionnaires completed at week zero will be considered the reference point for comparison with all future assessments and will be signed by the legal guardian.
2. Complete all assessment questionnaires fully, honestly, and based on the child’s actual behavior during the previous four weeks.
3. Complete the questionnaires again before each consultation session so that treatment progress can be monitored.
4. Allow clinical information, laboratory results, and questionnaire data to be used for documentation, scientific publication, and medical conferences, provided that the patient’s identity remains fully protected.

Important Notice:

Scientific publication of data is subject to approval by a recognized research ethics committee. If such approval is not obtained, the data will only be used internally for treatment quality improvement.

Consent for Publication on Social Media — Entirely Optional

If consent is given, images or videos may be used for public educational purposes only, with full facial masking and without publishing the patient’s name or identifying information.

Section Six: Confidentiality of the Treatment Protocol

The designed protocol is a specialized and individualized medical program. The legal guardian is respectfully requested to:

1. Not transfer protocol information, dosage details, or treatment sequences to medical centers or third parties for implementation without written permission from Dr. Sotoudeh.
2. Understand that the protocol has been designed specifically for this patient. Using it for other individuals without independent medical evaluation may create serious risks.

This is a professional and ethical request, not a legal restriction. The family always retains the right to seek a second opinion from another physician.

Section Seven: Rights of the Legal Guardian and Patient

The legal guardian or parent has the following full rights:

The right to receive complete and honest information about every aspect of the treatment.

The right to refuse any part of the treatment at any time without affecting other rights.

The right to withdraw consent at any time.

The right to seek a second opinion from another physician, including showing the protocol to a consulting physician.

The right to access all medical records.

The right to ask questions from the treating physician before and during the treatment.

Section Eight: Informed Confirmation and Signatures

I, the undersigned, as the parent / legal guardian of the above-mentioned patient, confirm by signing this consent form that:

•  i have fully read this form, have had it available for at least 48 hours, and have understood its contents. have had the opportunity to ask questions from the treating physician and have received answers to my questions.
• am fully aware of the experimental and off-label nature of some of the medications.
• am aware of the estimated monthly cost of USD 1,500 for medications and the separate consultation fee of ________________________ per consultation session, maximum 30 minutes.
• understand that at least five months may be required to observe an initial response, and that no guarantee exists.
• understand that my child may temporarily worsen, especially at the beginning of treatment with folinic acid, and that this phenomenon is usually transient.
• am fully aware of the aripiprazole–Methylene Blue interaction warning and the risk of serotonin syndrome.
• understand that psychiatric medications must not be changed without consulting the prescribing physician.
• understand that medication supply is the responsibility of the family and that Dr. Sotoudeh may assist in obtaining peptides from reliable sources in the United Arab Emirates.
• undertake to complete the questionnaires at week zero, baseline, and before each consultation session. sign this consent form freely and without coercion.