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Adipose Cells for Degenerative Disc Disease

Primary Purpose

Degenerative Disc Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Adipose Stem Cells

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Degenerative Disc Disease, Disc Disease, Back pain, stem cells, adipose stem cells, ADSCs

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Degenerative disease of one, two, or three lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months.
Fibrous ring capable of holding the cell implantation, demonstrated by RMI image
Absence of spinal infection.
Haematological and biochemical analysis with no significant alterations that contraindicates intervention.
The patient is able to understand the nature of the study.
Informed written consent of the patient.

Exclusion Criteria:

Congenital or acquired diseases leading to spine deformations that may upset cell application.
Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study
Modic III changes on MRI images (31).
More than 50% loss of height
Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
Life expectancy < 6 months due to concomitant illnesses.
Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status
Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
Patients on chronic immunosuppressive transplant therapy
Systolic blood pressure (supine) ≤90 mmHg or greater than 180mmHg
Resting heart rate > 100 bpm;
Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
Active clinical infection
Unwilling and/or not able to give written informed consent.
Recent smoking history or substance abuse (within six weeks)
Use of > 20 alcoholic drinks per week
Patients on Plavix or equivalent platelet inhibitors

Sites / Locations

US Stem Cell Clinic

Outcomes

Primary Outcome Measures

Visual Analog Scale

This is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot be directly measured.

Secondary Outcome Measures

Oswestry

Low back questionnaire designed to determine how low back pain has affected your daily life.

Full Information

NCT ID

NCT02097862

First Posted

March 25, 2014

Last Updated

March 15, 2017

Sponsor

Bioheart, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02097862

Brief Title

Adipose Cells for Degenerative Disc Disease

Official Title

An Open Label, Non-Randomized, Multi-Center Study To Assess The Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra-Discally in Patients With Degenerative Disc Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bioheart, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed degenerative disc disease.

Detailed Description

This will be an open-label, non-randomized, multi-center study of ASC implantation performed intra-discally. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The adipose tissue specimen will be collected from the patient's abdomen using a liposuction cannula. In addition, a sample of peripheral blood will be collected for isolation of platelet rich plasma. The adipose tissue is processed for separation of the adipose tissue-derived stem cells, which are then resuspended in platelet rich plasma and transferred for intra-discal administration. The number of cells injected will vary depending on the amount of tissue processed and the number of cells obtained from the process. Following the injections follow-up data will be collected 3, 6 and 12 months after treatment. Total study time frame is anticipated to be approximately 6 months. This study will enroll approximately 100 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Disc Disease

Keywords

Degenerative Disc Disease, Disc Disease, Back pain, stem cells, adipose stem cells, ADSCs

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Adipose Stem Cells

Intervention Description

Injection of adipose derived stem cells intra-discally

Primary Outcome Measure Information:

Title

Visual Analog Scale

Description

This is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot be directly measured.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Oswestry

Description

Low back questionnaire designed to determine how low back pain has affected your daily life.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Degenerative disease of one, two, or three lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months. Fibrous ring capable of holding the cell implantation, demonstrated by RMI image Absence of spinal infection. Haematological and biochemical analysis with no significant alterations that contraindicates intervention. The patient is able to understand the nature of the study. Informed written consent of the patient. Exclusion Criteria: Congenital or acquired diseases leading to spine deformations that may upset cell application. Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study Modic III changes on MRI images (31). More than 50% loss of height Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study Life expectancy < 6 months due to concomitant illnesses. Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results Patients on chronic immunosuppressive transplant therapy Systolic blood pressure (supine) ≤90 mmHg or greater than 180mmHg Resting heart rate > 100 bpm; Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. Active clinical infection Unwilling and/or not able to give written informed consent. Recent smoking history or substance abuse (within six weeks) Use of > 20 alcoholic drinks per week Patients on Plavix or equivalent platelet inhibitors

Facility Information:

Facility Name

US Stem Cell Clinic

City

Sunrise

State/Province

Florida

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28086781

Citation

Comella K, Silbert R, Parlo M. Effects of the intradiscal implantation of stromal vascular fraction plus platelet rich plasma in patients with degenerative disc disease. J Transl Med. 2017 Jan 13;15(1):12. doi: 10.1186/s12967-016-1109-0. Erratum In: J Transl Med. 2017 May 22;15(1):108.

Results Reference

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Adipose Cells for Degenerative Disc Disease

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