FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy

Bundang CHA Hospital

Status and phase: Withdrawn; Phase 2

Conditions: Cerebral Palsy

Treatments: Other: Active Rehabilitation; Biological: Umbilical Cord Blood Infusion; Other: Placebo Umbilical Cord Blood

Study type: Interventional

Funder types: Other

Identifiers

NCT01486732

CP FLT-PET

Details and patient eligibility

About

This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.

Full description

FLT(3'-Deoxy-3'-[F-18]Fluorothymidine) has been developed as a cell-proliferation tracer. In animal study, FLT-PET was used as a tool that enables imaging and measuring of proliferation in the brain, thus it detects activity of endogenous neural stem cells noninvasively. This study aims to assess cell proliferation activity changes in the brain after Umbilical Cord Blood (UCB)Therapy for Cerebral Palsy patients using FLT-PET.

Sex: All

Ages: 6 months to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cerebral Palsy
• Abnormal muscle tone
• Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
• Willing to comply with all study procedure

Exclusion criteria

• Medical instability including pneumonia or renal function at enrollment
• Presence of known genetic disease
• Presence of drug hypersensitivity which is related to this study remedy
• Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up
• Decision by the principal investigator when there are unexpected events including brain surgery, that may affect the outcome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Umbilical Cord Blood & Rehabilitation

Experimental group

Description:

Allogeneic umbilical cord blood infusion and active rehabilitation

Treatment:

Other: Active Rehabilitation

Biological: Umbilical Cord Blood Infusion

Placebo Umbilical Cord Blood & Rehabilitation

Active Comparator group

Description:

Placebo Umbilical Cord Blood infusion and active rehabilitation

Treatment:

Other: Active Rehabilitation

Other: Placebo Umbilical Cord Blood