STEM CELL THERAPY CONSENTS

Patient's Full Name

First NameLast Name

Patient's Date of Birth

DOB

Notice of Privacy Practices (NPP) Acknowledgment

45 C.F.R. § 164.520 | Fla. Stat. § 456.057

Federal law (45 C.F.R. § 164.520) requires Better Stem Corp to provide patients with a Notice of Privacy Practices (NPP). You have the right to review a full copy before signing. A copy is available at the front desk and on our website. Refusing to sign this acknowledgment will not affect your care.

How PHI Is Used. Without your written authorization, we may use and disclose PHI for treatment, payment, and healthcare operations. (45 C.F.R. § 164.506)
Electronic Transmission. PHI is transmitted electronically via HIPAA-compliant, encrypted connections. Business Associates maintain equivalent safeguards under signed BAAs (45 C.F.R. §§ 164.308–318).

Breach Notification. In the event of a PHI breach, we will notify you within 60 days of discovery as required by 45 C.F.R. §§ 164.400–414 and Fla. Stat. § 501.171.
Telehealth. Consultations may occur by phone, Zoom, or HIPAA-compliant platforms. Telehealth risks include possible privacy breach due to internet transmission. (Fla. Stat. § 456.47)

Marketing / Sale of PHI. We will NEVER use or disclose PHI for marketing with remuneration or sell PHI without explicit written authorization. (45 C.F.R. §§ 164.508(a)(3)–(4))

Minors. PHI is shared with parents/guardians as permitted by law. Certain sensitive information (mental health, substance abuse, STI) has additional protections under Fla. Stat. §§ 394.4615, 397.501, 384.29.

Refusing to Sign. You may refuse. We will document the attempt per 45 C.F.R. § 164.520(c)(2)(ii). Refusal does not affect your right to treatment.

Your Rights Include:
• Access / copy your records within 30 days (45 C.F.R. § 164.524; Fla. Stat. § 456.057(6))
• Request amendment of incorrect records (45 C.F.R. § 164.526)
• Request restrictions on uses/disclosures (45 C.F.R. § 164.522)
• Receive an accounting of disclosures for prior 6 years (45 C.F.R. § 164.528)
• File a complaint with HHS OCR: 1-877-696-6775 | hhs.gov/ocr/privacy — no retaliation
Privacy Officer: Remco Bos | rbos@betterstem.com | 305-786-5901 | NPP Effective: January 1, 2026

Signature of Parent / Legal Guardian

Parent/Legal Guardian's Name

Relationship to the Patient

Today's Date

Date

Florida Mandatory Stem Cell Consent

Fla. Stat. § 458.3245 (enacted SB 1768, effective 2025) | Fla. Stat. §§ 456.072, 458.331

Florida law (Fla. Stat. § 458.3245) requires a physician performing stem cell therapy that has not been approved by the U.S. Food and Drug Administration (FDA) to obtain a signed consent form containing each of the following disclosures, in language the patient or representative may reasonably be expected to understand.

THIS PHYSICIAN PERFORMS ONE OR MORE STEM CELL THERAPIES THAT HAVE NOT YET BEEN APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION. YOU ARE ENCOURAGED TO CONSULT WITH YOUR PRIMARY CARE PROVIDER BEFORE UNDERGOING ANY STEM CELL THERAPY.

1. Nature and Character of the Proposed Treatment (Fla. Stat. § 458.3245(6)(b)1)

The proposed treatment consists of non-FDA-approved stem cell therapy using Mesenchymal Stem Cells (MSCs) -specifically AlloRx Stem Cells® manufactured by Vitro Biopharma, Inc. — administered via intravenous (IV) infusion. This therapy involves the use of human cells, tissues, or cellular and tissue-based products (HCT/Ps) as regulated under 21 C.F.R. Part 1271. Additional protocol elements may include: folinic acid supplementation, FRAT testing, gut health support, and metabolic workup as part of BetterStem’s proprietary multi-modal autism protocol.

2. FDA Approval Status (Fla. Stat. § 458.3245(6)(b)2)

The proposed stem cell therapy described above has NOT been approved by the United States Food and Drug Administration (FDA) for the treatment of Autism Spectrum Disorder (ASD) or for any other indication. The stem cell product used (AlloRx Stem Cells®) is administered under the federal Right-to-Try Act (21 U.S.C. § 360bbb-0a) and/or BetterStem’s IRB-approved protocol. This does not constitute FDA approval of the therapy.

I understand and acknowledge that the proposed stem cell therapy is NOT FDA-approved.

Yes, I understand and acknowledge the above.

3. Anticipated Results of the Proposed Treatment (Fla. Stat. § 458.3245(6)(b)3)

Potential benefits that have been observed in some patients may include improvements in: social communication and interaction, behavioral flexibility, sensory processing, adaptive functioning, and overall quality of life. No specific outcome is guaranteed. Individual responses vary significantly. No claims are made that this therapy cures or definitively treats ASD.

Specific anticipated results discussed with me by my treating physician: Improvement of the ASD symptoms and better quality of life.

4. cognized Serious Possible Risks, Complications, and Anticipated Benefits (Fla. Stat. § 458.3245(6)(b)4)

Risks associated with IV stem cell infusion include but are not limited to:

• Infection at infusion site or systemic infection

• Allergic or hypersensitivity reaction (including anaphylaxis — rare but serious)

• Infusion reactions (fever, chills, nausea) during or within hours of treatment

• Phlebitis or thrombosis at the IV site

• Immune activation or inflammatory response

• Graft-versus-host disease (rare with allogeneic cells)

• Transmission of infectious disease (risk minimized through FDA-regulated product sourcing)

• Unknown long-term effects — this therapy has not been studied in long-term FDA-approved trials

• Tumor formation — theoretical risk with stem cell use; no known cases with MSC IV infusions to date

• Treatment may have no effect — non-response is a recognized outcome

5. Recognized Possible Alternative Forms of Treatment, Including Non-Treatment (Fla. Stat. § 458.3245(6)(b)4)

The following alternatives have been discussed with me:

• Applied Behavior Analysis (ABA) therapy

• Speech-language therapy

• Occupational therapy

• Behavioral and developmental interventions

• FDA-approved medications for ASD-associated symptoms (e.g., aripiprazole, risperidone for irritability)

• No treatment / watchful waiting

6. Primary Care Provider Consultation Advisement (Fla. Stat. § 458.3245(6)(b)5)

You are encouraged and have the right to consult with your child’s primary care provider before undergoing any stem cell therapy. Better Stem Corp recommends this consultation and will provide a summary of the proposed treatment to share with your PCP upon request.

I understand and acknowledge that the proposed stem cell therapy is NOT FDA-approved

I have consulted / plan to consult with my primary care provider before treatment

Patient's Name: {q3_fullname1}

DOB: {q4_datetime2}

Name of the signer: {q6_textbox4}

Relationship to the Patient: {q7_textbox5}

Today's Date: {q8_datetime6}

Signature of Parent / Legal Guardian

Informed Consent for Medical Treatment

Fla. Stat. § 766.103 (Florida Medical Consent Law) | 21 C.F.R. § 50.25 | Fla. Stat. § 381.026 (Patient’s Bill of Rights)

1. Nature of the Proposed Treatment
Treatment(s) may include MSC stem cell IV infusions via AlloRx Stem Cells® and any additional protocol elements mutually agreed upon (e.g., folinic acid, FRAT testing, gut health, metabolic workup). All treatments will be discussed and agreed upon before administration.

2. Purpose and Expected Benefits
Potential benefits discussed by treating provider (fill in): Improvement of autism symptoms and quality of life.

3. Material Risks and Side Effects (Fla. Stat. § 766.103(3)(a))

A reasonably prudent patient would consider the following risks material. They have been discussed with me: infusion-site infection, allergic/hypersensitivity reaction, infusion reaction (fever/chills/nausea), phlebitis, immune response, unknown long-term effects, and possibility of no benefit.

4. Alternatives Including Non-Treatment (Fla. Stat. § 766.103(3)(a))

Discussed alternatives include: ABA therapy, speech/language therapy, occupational therapy, FDA-approved medications for ASD symptom management, no treatment.

5. Right to Withdraw / Florida Patient’s Bill of Rights
I may withdraw consent at any time before or during treatment without penalty. Under Fla. Stat. § 381.026, I have the right to: respectful dignified care; privacy; information in a language I understand; and to file a complaint with AHCA at 1-888-419-3456.

6. Responsibility to Inform Provider of Changes
I understand I must inform Better Stem Corp of any changes in the patient’s health, medications, allergies, or other factors affecting treatment.

7. Duration of Consent
This consent remains valid for the duration of care under Better Stem Corp for the treatment(s) described, unless revoked in writing. New consent will be obtained for materially different or additional treatments.

8. Language Access
I confirm I have received this consent form in a language I understand. If translation assistance was provided, the interpreter’s information is noted below. (Updated March 1, 2024 per 21 C.F.R. Part 50 requirements for non-English speaking subjects.)

Patient's Name: {q3_fullname1}

DOB: {q4_datetime2}

Name of the signer: {q6_textbox4}

Relationship to the Patient: {q7_textbox5}

Today's Date: {q8_datetime6}

Signature of Parent / Legal Guardian

Consent for Use of Photographs and Videos

This consent is entirely voluntary. Refusing will NOT affect your treatment or care. Federal law (45 C.F.R. § 164.508(a)(2)) and Florida law (Fla. Stat. § 540.08 — Right of Publicity) require explicit written authorization before photographs or videos containing PHI or a person’s likeness may be used for marketing or commercial purposes.

Scope of Consent

Educational / clinical case study (internal training, CME, academic publications — de-identified where possible), website ,tv, and social media (Better Stem Corp owned channels), print materials (brochures, flyers, press materials).

This consent remains valid for the duration of care under Better Stem Corp for the treatment(s) described, unless revoked in writing. New consent will be obtained for materially different or additional treatments.

Terms and Conditions

License. For each use initialed above, I grant Better Stem Corp a non-exclusive, worldwide, royalty-free right to use, reproduce, publish, and display the materials.

HIPAA. I authorize use/disclosure of PHI in the form of photographs/videos for the specific purposes initialed above. (45 C.F.R. § 164.508(a)(2))

Florida Right of Publicity. I consent to commercial use of the patient’s name, likeness, portrait, or photograph for the purposes initialed above. (Fla. Stat. § 540.08)

No compensation. I will not receive financial compensation unless separately agreed in writing.

Right to revoke. I may revoke this consent in writing at any time. Revocation does not affect uses that already occurred.

Loss of control after publication. Once materials are published publicly, Better Stem Corp cannot guarantee they will not be further disseminated.

Legal authority. As the patient’s legal guardian, I confirm I have the legal authority to grant this consent on the patient’s behalf.

Patient's Name: {q3_fullname1}

DOB: {q4_datetime2}

Name of the signer: {q6_textbox4}

Relationship to the Patient: {q7_textbox5}

Today's Date: {q8_datetime6}

Signature of Patient / Legal Guardian

Is sedation part of the stem cell therapy plan?

Consent for Sedation

Parent / Legal Guardian Informed Consent for Moderate Sedation / Anxiolysis

1. Purpose of This Consent
The provider at BetterStem Corp has recommended that the child named above (“the patient”) receive sedation in connection with a regenerative medicine procedure. Sedation is used to reduce anxiety, minimize discomfort, and help the patient stay calm and comfortable during treatment. As the parent or legal guardian, I am being asked to give consent on the patient’s behalf. This document explains the type of sedation being offered, its benefits, risks, and alternatives, so that I can make an informed decision for the patient.

2. Sedation Option(s) Selected
I consent for the patient to receive the sedation medications and techniques recommended by the treating provider, including but not limited to those discussed with me prior to the procedure, as deemed medically appropriate to ensure the patient's safety, comfort, and successful completion of the treatment.

Versed (midazolam) Sedation — administered by intramuscular (IM) injection in the arm or buttock.

Ketamine Sedation — administered by intramuscular (IM) injection in the arm or buttock.

Dexamathasone – for nausea

Zofran – for nausea

Other (as described by provider)

The medication, dose, and route will be determined by the administering provider based on the patient’s age, weight, and medical history. Doses for children are calculated individually.

3. Expected Benefits
• Reduced anxiety and a greater sense of calm for the patient before and during the procedure.

• Decreased awareness of and discomfort from the procedure.

• Possible partial or complete amnesia (reduced memory) of the procedure, which is an expected effect of some sedatives.

• Greater ability of the care team to complete the procedure safely while the patient stays still and comfortable.

Sedation is intended to improve the patient’s comfort. It is not a guarantee of a pain-free experience or of any particular treatment outcome.

4. Risks and Possible Complications
All sedation carries risk, and children can be more sensitive to sedating medications than adults. While serious complications are uncommon, I understand they can occur and may include, but are not limited to, the following:

General risks of sedation:

• Drowsiness, dizziness, prolonged sedation, or slow recovery.

• Nausea or vomiting.

• Slowed or shallow breathing (respiratory depression) and, rarely, the need for supplemental oxygen or airway support.

• Changes in blood pressure, heart rate, or heart rhythm.

• Allergic or adverse reaction to the medication.

• Pain, bruising, bleeding, or infection at the injection site.

• Paradoxical reactions such as agitation, crying, or restlessness, which can occur more often in children.

• In rare cases, serious events including aspiration, respiratory or cardiac arrest, or death.

Additional risks specific to Ketamine:

• Vivid dreams, hallucinations, dissociation, or emergence reactions (confusion or agitation as the medication wears off).

• Increased blood pressure, heart rate, or salivation.

• Involuntary eye movements (nystagmus) or muscle movements; rarely, laryngospasm (tightening of the airway).

A reversal or rescue medication and emergency procedures may be used if needed. I understand the provider cannot anticipate or explain every possible risk.

5. Alternatives
Alternatives to the sedation described above have been explained to me and may include: proceeding without sedation, the use of local or topical anesthetic only, a different sedation medication, or declining the procedure altogether. I understand I may choose any available alternative or decline sedation for the patient entirely.

6. Before Sedation — My Responsibilities as Parent / Guardian
• I have disclosed the patient’s complete medical history, including all medications, supplements, vitamins, allergies, recent illnesses, and any history of prior reactions to sedation or anesthesia.

• I have followed all fasting (eating and drinking) instructions given for the patient.

• I have informed the provider of any chance that the patient could be pregnant, where applicable.

• I have arranged safe transportation home, including an appropriate car seat or booster as required for the patient’s age and size, and a responsible adult to supervise the patient afterward.

7. After Sedation — Caring for The patient
After sedation, the patient may be drowsy, unsteady, or fussy for several hours. I understand that for at least 24 hours, or until the provider says it is safe, I should:

• Keep the patient under the direct supervision of a responsible adult and not leave the patient unattended.

• Not allow the patient to engage in activities that require coordination or balance (such as biking, climbing, swimming, or sports) until fully recovered.

• Position the patient safely during travel and rest, and watch for normal breathing.

• Offer fluids and food gradually, as directed by the provider.

I will contact the provider or seek emergency care immediately if the patient has difficulty breathing, will not wake up or stay awake, has repeated vomiting, or shows any reaction that concerns me.

8. Acknowledgment and Consent
By signing below, I confirm that:

• I am the parent or legal guardian of the child named above and have the legal authority to consent to medical care, including sedation, on the child’s behalf.

• I have read, or have had read to me, this consent and I understand it.

• The provider has explained the proposed sedation, its purpose, benefits, risks, and alternatives, and has answered all of my questions to my satisfaction.

• I understand that the practice of medicine is not an exact science and that no guarantee has been made to me about the results of the sedation or procedure.

• I am consenting voluntarily on the patient’s behalf and have not been pressured to do so.

Patient's Name: {q3_fullname1}

DOB: {q4_datetime2}

Name of the signer: {q6_textbox4}

Relationship to the Patient: {q7_textbox5}

Today's Date: {q8_datetime6}

Patient's current weight:

Signature of Patient / Legal Guardian