Suspended

A Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Chronic Spinal Cord Injury.

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What is being tested

cellgram-spine

Drug
Who is being recruted

Central Nervous System Diseases+3

+ Nervous System Diseases

+ Spinal Cord Diseases

From 16 to 65 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: August 2008
See protocol details

Summary

Principal SponsorPharmicell Co., Ltd.
Last updated: March 23, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2008

Actual date on which the first participant was enrolled.

The Principal investigator has performed a clinical trial using autologous MSCs in patients with cervical spinal cord injury. The results revealed the safety of autologous MSC. This Phase II, III single-center trial is to assess the safety and efficacy of bone marrow-derived mesenchymal stem cell transplantation direct to injured spinal cord site via laminectomy. After recovery from the operation, the subjects receive 4 weeks of physical and occupational therapy.

NCT01676441
Principal SponsorPharmicell Co., Ltd.
Last updated: March 23, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Central Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesWounds and InjuriesTrauma, Nervous SystemSpinal Cord Injuries

Criteria

8 inclusion criteria required to participate
12 months or more post spinal cord injury subject with stable neurological finding after more than 1 month rehabilitation therapy
Able to consent by patients or legal representatives
Aged between 16-65 years
American Spinal Injury Association Impairment Scale B
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14 exclusion criteria prevent from participating
Drug abuse in the past 1 year
Inappropriate patients to participate in the study according to the chief investigator
Major surgical procedure in the past 3 months
Mechanical ventilation
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
posterior cervical laminectomy and Mesenchymal stem cells tranplantation. After laminectomy, 1.6X10^7 and 3.2 X10^7 Autologous Mesenchymal stem cells is injected into the intramedullary and intrathecal space respectively

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Asan medical center

Seoul, South KoreaOpen Asan medical center in Google Maps
SuspendedOne Study Center