NCT02338271

Brief Summary

  1. 1.Subject: 10 patients
  2. 2.Investigational Product
  3. 3.Time frame
  4. 4.1 year

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1 low-back-pain

Timeline
Completed

Started Jan 2015

Typical duration for phase_1 low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

2.9 years

First QC Date

January 7, 2015

Last Update Submit

January 13, 2015

Conditions

Low Back Pain

Keywords

Low back painMesenchymal stromal stem cellHyaluronic acid

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Safety and Tolerability (Adverse events)

    The transplantation will be considered to be safe and tolerable, in the absence of the following types of counter evidence. \- Adverse events of grade 3 (NCI grading system) or above related to the cell products/ any evidence that the cells were contaminated by pollutants / any evidence that the cells exhibit tumorigenic potential. Adverse events will be reported at 1, 3, 6, 9, and 12 months

    12months

Secondary Outcomes (5)

  • Change in the T2 MRI signal intensity of the nucleus pulposus

    12months

  • Overall improvement in the Disc Height Index

    12months

  • improvement in Visual Analogue Scale (VAS)

    12 months

  • improvement in Oswestry Disability Index (ODI)

    12 months

  • improvement in Short Form-36

    12 months

Study Arms (1)

a single, open clinical trial

OTHER

a single-group, open, investigator-initiated clinical study : autologous adipose derived mesenchymal stem cell (2 x 10\^7 cells/mL /vial or 4 x 10\^7 cells/mL /vial) plus Tissuefill (hyaluronic acid derivatives) 1mL/syringe

Other: autologous adipose derived mesenchymal stem cell

Interventions

autologous adipose derived mesenchymal stem cellOTHER

autologous adipose derived mesenchymal stem cell (2 x 10\^7 cells/mL /vial or 4 x 10\^7 cells/mL /vial) and Tissuefill (hyaluronic acid derivatives) 1mL/syringe

a single, open clinical trial

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have experienced pain in the lower back or buttocks who have failed to respond to conservative therapies performed for a period of 3 months or longer.
  • Oswestry Disability Index of 30% or higher.
  • Visual Analogue Scale of 4 or higher.
  • Subjects who have received a Magnetic Resonance Imaging (hereinafter referred to as MRI) assessment of grades 3 to 4 for Lumbar 1 - Sacral 1, according to the Pfirrmann grading system.
  • Subjects who are assessed to have a similar degree of pain as usual when a discogram is performed on the degenerative lumbar disc(s) identified by MRI, having one or two discs that cause the pain.
  • Subjects who have signed the informed consent form for stem cell transplantation therapy.

You may not qualify if:

  • Subjects with severe lumbar stenosis or herniated nucleus pulposus in the lumbar exhibiting symptoms of nerve compression and requiring surgery.
  • Subjects with spinal instability, spondylitis, or vertebral fractures
  • Patients with severe intervertebral disc degeneration that has resulted in a reduction of the disc height by ½ or more.
  • Subjects with severe osteoporosis (with an average T-score of -2.5 or below in the lumbar bone density test)
  • Patients who have received intra-discal procedures such as stem cell therapy or the injection of steroids into the disc or surgery such as discectomy on the disc on which the cell transplantation is planned to be performed.
  • Patients who have received a lumbar epidural steroid injection within a week prior to the cells transplantation.
  • Subjects who are hypersensitive to sodium hyaluronate.
  • Pregnant or breastfeeding women
  • Female patients with the possibility of pregnancy during the period of the clinical study who are not using a medically acceptable method of contraception.
  • \* Medically acceptable methods of contraception: condoms, an oral contraceptive administered continually for at least 3 months, an implantable contraceptive surgically inserted 3 months prior to the clinical study, injected or inserted contraceptives, an intrauterine contraceptive device, etc.
  • Subjects with mental illness or a drug or alcohol addiction or subjects who are incapable of understanding the purpose and method of this clinical study.
  • Subjects who have participated in another clinical study in the 30 days prior to this study.
  • Subjects with a severe medical disease (hypertension unresponsive to drug treatment, diabetes unresponsive to drug treatment, hepatocirrhosis, renal failure, tumor) that can affect the outcome of this clinical study.
  • Subjects with any other clinically significant findings that renders the subject unsuitable for the clinical study, as judged by the investigator responsible for the clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA University, CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 463-712, South Korea

RECRUITING

Related Publications (1)

  • Kumar H, Ha DH, Lee EJ, Park JH, Shim JH, Ahn TK, Kim KT, Ropper AE, Sohn S, Kim CH, Thakor DK, Lee SH, Han IB. Safety and tolerability of intradiscal implantation of combined autologous adipose-derived mesenchymal stem cells and hyaluronic acid in patients with chronic discogenic low back pain: 1-year follow-up of a phase I study. Stem Cell Res Ther. 2017 Nov 15;8(1):262. doi: 10.1186/s13287-017-0710-3.

    PMID: 29141662DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Inbo Han, MD, PhD

    CHA Bundang Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Inbo Han, MD, PhD

CONTACT

+82-31-780-5688hanib@cha.ac.kr

Kyunghoon Min, MD

CONTACT

+82-31-780-5688minkh@chamc.co.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Spine Neurosurgeon

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 14, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

KR(1)