Treatment of Sequelae Caused by Severe Brain Injury With Autologous Adipose-derived Mesenchymal Stem Cells

National Yang Ming Chiao Tung University

Status and phase: Completed; Phase 2; Phase 1

Conditions: The Sequelae Caused by Severe Brain Injury

Treatments: Biological: autologous adipose-derived mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01649700

SB-VGH-201101

Details and patient eligibility

About

The study is to investigate the efficacy and safety of autologous transplantation of adipose-derived mesenchymal stem cells in patients with the sequelae caused by severe brain injury.

Enrollment: 1 patient

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has a confirmed diagnosis of a brain AVM (arteriovenous malformation).
• Stroke-like symptoms, including paralysis, caused by brain AVM hemorrhage.
• Subject's modified Rankin scale (mRS) grades IV~V.
• Ages between 20~40 years.
• Estimated life expectancy must be greater than 2 months.
• Signed informed consent from the subject.

Exclusion criteria

• Pregnancy test positive.
• Subject infected with hepatitis C, HIV or syphilis.
• Subject not suitable for liposuction surgery.
• Subject not eligible for PET or MRI.
• Subject enrolled in any other cell therapy studies within the past 30 days.
• Subject deemed to be not suitable for the study by the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Mesenchymal stem cells treatment

Experimental group

Description:

All subjects will receive autologous adipose-derived mesenchymal stem cells

Treatment:

Biological: autologous adipose-derived mesenchymal stem cells