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Multiple SclerosisPhase 1NCT02326935

Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells for the Treatment of Multiple Sclerosis

A Phase 1 study testing Autologous adipose derived mesenchymal cells in people with Multiple Sclerosis, run by American CryoStem Corporation at 1 site in Cayman Islands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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 Multiple Sclerosis and clinical outcomes. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Autologous adipose derived mesenchymal cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteCayman Islands
Study dates
Nov 2014to 18 May 2018
Phase
Phase 1
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed Diagnosis of MS
  • Aged 18 - 65 years.
  • Duration of disease: >5 years
  • Signed, written informed consent willing and able to comply with study visits according to protocol for the full study period
  • Physically, mentally and legally capable of international travel for treatment

Who cannot join

  • Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results
  • Patient with any active or chronic infection
  • No life-threatening organ dysfunction.
  • Pregnancy or risk of pregnancy.
  • Severe physical limitations or disabilities
  • Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C
Show all 9Show fewer
  • Patients unable to give written informed consent in accordance with research ethics board guidelines
  • Treatment with any immunosuppressive therapy within the 3 months prior to randomization
  • Current treatment with an investigational therapy

Trial locations and contacts

1 site in 1 country.

Cayman Islands1 site

  • The Da Vinci Center

    George Town, KY1-1205

About this study

Official title: Proposal for a Non-randomized, Patient Sponsored, Multi-center Study Studying the Impact and Safety of the Utilization of Culture Expanded Autologous, Adipose-derived Mesenchymal Stem Cells Deployed Via Intravenous Injection for the Treatment of Multiple Sclerosis

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 Multiple Sclerosis and clinical outcomes.

Read the detailed description

This will be an open-label, non-randomized multi-center patient sponsored study of ADSC implantation using an IV delivery system. The study will provide therapies to up to 100 qualified patients who match the inclusion/exclusion criteria, agree to the follow up program and who have provided a signed consent for each procedure.

The treatment is a combination of (a) general detoxification, (b) lymphatic massage/drainage, (c) therapeutic massage, reflexology and acupuncture and (d) cellular infusion therapy in which cells will be deployed via IV injection over two treatments of 60 minutes each during the five (5) day treatment period.

Follow-up data based upon MSIS-29, a modified SF-36 and standard complication questionnaire will be collected at 3, 6 and then annually post treatment by the patients' local physician and reported back to the sponsor where it will be logged into a HIPPA-compliant outcomes database.

Additional safety data, based upon a standard complication questionnaire will be collected via survey of patient at intervals of 3 and 6 months and then annually for a minimum of five (5) years.

Being tested
Autologous adipose derived mesenchymal cells
Keywords
MS, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Myelitis
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Myelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous adipose derived mesenchymal cellsBiological

    Also called ADSC, mesenchymal cells, stromal cells

    Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection.

Study groups in NCT02326935
Study groupRoleWhat they receive
Adipose derived mesenchymal cellsExperimentalIntervention: Autologous adipose derived mesenechymal stem cells, 150 million cells deployed via two (2) treatments via intravenous injection Other Names: ADSC, mesenchymal cells, stromal cells
Receives: Biological: Autologous adipose derived mesenchymal cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Standard Complication Questionnaire

    incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed

    Measured: 3 months

  2. MS Impact Scale - MSIS-29

    Multiple Sclerosis Impact Scale (MSIS-29)

    Measured: 3 months

  3. Modified SF-36 Cell-Based Therapy Follow Up

    Modified SF-36 for Cell-Based Therapy Follow Up

    Measured: 3 months

  4. Physical Evaluation

    Vital signs of sitting blood pressure, temperature and heart rate

    Measured: 3 Months

Secondary outcomes (11)

  1. MS Impact Scale - MSIS-29

    Multiple Sclerosis Impact Scale (MSIS-29)

    Measured: 6 months

  2. MS Impact Scale - MSIS-29

    Multiple Sclerosis Impact Scale (MSIS-29)

    Measured: 1 year

  3. Modified SF-36 Cell-Based Therapy Follow Up

    Modified SF-36 for Cell-Based Therapy Follow Up

    Measured: 6 months

  4. Standard Complication Questionnaire

    incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed

    Measured: 6 months

  5. Standard Complication Questionnaire

    incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed

    Measured: 1 year

  6. Standard Complication Questionnaire

    incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed

    Measured: 2 years

  7. Standard Complication Questionnaire

    incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed

    Measured: 3 years

  8. Standard Complication Questionnaire

    incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed

    Measured: 4 years

  9. Standard Complication Questionnaire

    incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed

    Measured: 5 years

  10. Physical Evaluation

    incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed

    Measured: 6 months

  11. Physical Evaluation

    incidence and nature of adverse events, serious adverse events, or any unanticipated adverse events. The nature, incidence, and rate of adverse events will be assessed

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion18 May 2018
  4. Study completion18 May 2018

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02326935
Sponsor's protocol ID
CRYO-MS-ADSC-006
Status last verified
May 2018
First submitted
18 Dec 2014
Last updated
22 May 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous adipose derived mesenchymal cells in people with Multiple Sclerosis, run by American CryoStem Corporation at 1 site in Cayman Islands.

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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 22 May 2018. 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 Cayman Islands. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

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?

Standard Complication Questionnaire (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT02326935.

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 22 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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