Healthcare Stem Cells Consent Form

HEALTHCARE STEM CELLS CONSENT FORM

Patient Information

Patient Name:    Date of Birth:    Gender:

Emergency Contact

Insurance Information

Medical History

Procedure and Intended Use

Procedure / Treatment Description:

Intended procedure date:

Select intended source and disposition of stem cells (select all that apply):

Autologous (stem cells collected from the patient)    Allogeneic (stem cells from a donor)

I consent to cryopreservation and storage of my stem cells.    Storage duration or instructions:

I consent to de-identified use of my stem cells for research purposes as described below.

Risks, Benefits, and Alternatives

I have been informed of the nature and purpose of the collection and/or administration of stem cells and the associated procedures. The benefits include potential therapeutic effect and improved tissue regeneration, but no guarantee of benefit is made. Risks include, but are not limited to:

• Infection, bleeding, or injury at collection or administration sites
• Allergic or immune reaction to cells or materials used
• Failure to achieve intended clinical benefit
• Unknown or unanticipated long-term effects, including tumorigenicity
• Possible need for additional procedures or treatments

Alternatives to this procedure have been explained to me, including no treatment, conventional therapies, and participation in alternative clinical protocols where applicable.

I acknowledge that the risks and benefits described above were explained to me and that I had the opportunity to ask questions.

I acknowledge that reasonable alternatives were explained and I understand them.

Right to Withdraw and Revocation

I understand that I have the right to withdraw this consent at any time prior to the collection and/or administration of stem cells by providing written notice to the treating facility. Withdrawal of consent will not affect my right to future medical care.

I acknowledge my right to withdraw consent and understand the procedure to do so.

HIPAA and Privacy Acknowledgment

I authorize the release of relevant medical information related to the collection, processing, storage, and use of my stem cells to treating clinicians and entities reasonably involved in the handling and storage of my cells. I understand that identifiable health information will be protected in accordance with applicable privacy standards, and de-identified information may be used for research if I have given consent above.

I acknowledge the privacy practices described above and consent to the disclosures necessary for treatment, storage, and (if selected) research.

Release and Certification

I hereby authorize the named procedures and the handling of my stem cells as described herein. I release and hold harmless the treating physicians, staff, facility, and agents from liability for complications arising from the authorized procedures except in cases of gross negligence or willful misconduct.

Treating Physician or Responsible Clinician:    Facility:

I certify that I have read and fully understand this form, that all my questions have been answered to my satisfaction, and that I consent voluntarily to the collection, storage, and use of my stem cells as indicated above.

Patient Certification

By signing below I certify that I am the patient or the legally authorized representative of the patient, that I have the authority to execute this consent, and that I understand the information, risks, benefits, and alternatives explained above.

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