Degenerative Disc DiseaseNCT02097862
Adipose Cells for Degenerative Disc Disease
A study testing Adipose Stem Cells in people with Degenerative Disc Disease, run by Bioheart, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Adipose Stem Cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Degenerative Disc Disease
- Being tested
- Adipose Stem Cells
- Keywords
- Degenerative Disc Disease, Disc Disease, Back pain, stem cells, adipose stem cells, ADSCs
- Medical subject headings
- Intervertebral Disc Degeneration, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose Stem CellsProcedure or surgery
Injection of adipose derived stem cells intra-discally
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Oswestry
Low back questionnaire designed to determine how low back pain has affected your daily life.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioheart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097862
- Sponsor's protocol ID
- ADI-US-DDD-001
- Status last verified
- Mar 2017
- First submitted
- 25 Mar 2014
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28086781
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02097862
- Acronym / sponsor ID
- ADI-US-DDD-001
- Conditions
- Degenerative Disc Disease
- Keywords
- Degenerative Disc Disease, Disc Disease, Back pain, stem cells, adipose stem cells, ADSCs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bioheart, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose Stem CellsInjection of adipose derived stem cells intra-discally | Procedure or surgery | – |
Primary outcome
Visual Analog Scale
Time frame: 12 months
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.
1 secondary outcome
Oswestry
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Background: PubMed 28086781Comella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adipose Stem Cells in people with Degenerative Disc Disease, run by Bioheart, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02097862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017; AzTrials last refreshed its copy on 2 Nov 2026.