Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury

NCT01624779 | Completed Phase 1

• 1 other identifier: KOR-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of intrathecal transplantation of autologous adipose tissue derived mesenchymal stem cells in the patients with spinal cord injury, Phase I Clinical study.

Conditions

Spinal Cord Injury

Keywords

autologous adipose tissue

Outcome Measures

Primary Outcomes (1)

• Significant MRI Change before and after intervention

  6 month

Secondary Outcomes (3)

• Significant neurologic funtion Change before and after intervention

  6 month

• Significant Electrophysiological Change before and after intervention

  6 month

• Adverse event

  6 month

Interventions

autologous adipose tissue derived mesenchymal stem cells DRUG

autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1\&2

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who don't have any possiblity of improving neurological function despite performed the optimal treatment after spinal cord injury
• No change in neurological function for 4weeks interval by at least 2 clincal medical specialists
• Patient who is able to give written informed consent of clinical trial about stemcells treatment

You may not qualify if:

• Patient who is under 19 years and over 70years
• Patient who must use the mechanical ventilator
• Patient who have a history of malignant tumor within 5 years
• Patient who is having a infectious disease of including current hepatitis and HIV
• Patient who had the brain or spinal cord injury before the spinal cord injury (confirm subject's history from their medical history)
• Patient who is having a acute disease judged by principle investigator or having a fever over 38.0 ℃ at the vaccination day
• Patient who is having an anemia or thrombopenia
• Patient who is having an angina, myocardial infarct, myocardiopathy, obstructive vessel disease, chronic renal failure, glomerulopathy and chronic obstruent lung disease (confirm subject's history from their medical history)
• Patient who is having a Congenital Immune Deficiency Syndrome or AIDS (confirm subject's history from their medical history)
• Patient who is having an amyotrophia or joint atrophy
• Patient who is having an disturbanace of consciousness or dysphrasia
• Patient who is taking an immunosuppressive agents or corticosteroids agents or cytotoxic agents or needed administration
• Patient who have experienced another clinical trials within 3 months involving this clinical trial
• Patient who can't participate in this clinical trial having any opinion regarded as clinical significance judged by principle investigator

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, Seongbukgu, 136-705, South Korea

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Taehyeong Jo, PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 21, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 13, 2015

Record last verified: 2012-06

Locations

KR (1)