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Prostate CancerPhase 1MSCNCT01983709

Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer

A Phase 1 study testing Allogeneic Human Mesenchymal Stem Cells in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Terminated

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

Official record
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Trial summary

The objective of this study is to determine if systemically infused allogeneic bone marrow derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized adenocarcinoma of the prostate that are planning to undergo a prostatectomy. Read more about this study

Who is it for?
Ages 18 to 100 years, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
Allogeneic Human Mesenchymal Stem Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
Oct 2013to Jun 2017
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 100 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years, ≤30 years
  • Male sex
  • Donor must meet the selection and eligibility criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT) and FDA 21 CFR Part 1271
  • Age ≥18 years
  • Eastern cooperative group (ECOG) performance status ≤2
  • Documented histologically confirmed adenocarcinoma of the prostate
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  • Gleason score on diagnostic biopsy specimens of ≥ 6
  • ≥ 3 positive cores within diagnostic biopsy specimens
  • At least one prostate core must contain ≥ 30% prostate cancer
  • Scheduled to undergo a prostatectomy at Johns Hopkins
  • Has not received systemic therapy for prostate cancer (i.e. LHRH agonist/antagonist therapy)
  • Sexual Health Inventory in Men (SHIM) score ≥ 17

Who cannot join

  • Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
  • Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  • Inability to provide informed consent.
  • MSC Recipients
  • Prior radiation therapy to the prostate.
  • Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
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  • Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  • Inability to provide informed consent.
  • Any active autoimmune disease requiring treatment (e.g. steroid, disease-modifying antirheumatic drugs, biologic agents, etc.).
  • Prior history of penicillin or streptomycin allergy.
  • No prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study.
  • Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)
  • Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
  • Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study.
  • History of symptomatic pulmonary dysfunction.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: A Phase 1 Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer

The objective of this study is to determine if systemically infused allogeneic bone marrow derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized adenocarcinoma of the prostate that are planning to undergo a prostatectomy. Investigators plan to systemically infuse MSCs 4, 6 or 8 days prior to enrolled subjects' planned prostatectomies. Investigators will then quantify the relative amount of donor MSC DNA to recipient DNA present in patients' explanted prostate specimens. This will be accomplished via BEAMing digital PCR. This trial will provide the foundation for future studies aimed at engineering MSCs to deliver a toxin to sites of metastatic prostate cancer.

Conditions
Prostate Cancer
Being tested
Allogeneic Human Mesenchymal Stem Cells
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Allogeneic Human Mesenchymal Stem CellsBiological

    This will be a dose escalation study. The first 3 subjects will receive a single dose of 1 x 10^6 cells/kg or a maximum dose of 1 x 10^8 total cells IV 4 days prior to undergoing a planned prostatectomy.

    The remaining subjects will receive a single dose of 2 x 10^6 cells/kg or a maximum dose of 2 x 10^8 total cells IV either 4 or 6 days prior to the planned prostatectomy, and if additional doses of MSCs are able to be expanded, up to 6 additional men will be enrolled with a plan to treat them 8 days prior to the prostatectomy.

Study groups in NCT01983709
Study groupRoleWhat they receive
Allogeneic Human Mesenchymal Stem CellsExperimentalThis will be a dose escalation study. The first 3 subjects will receive a single dose of 1 x 10^6 cells/kg or a maximum dose of 1 x 10^8 total cells IV. The remaining subjects will receive a single dose of 2 x 10^6 cells/kg or a maximum dose of 2 x 10^8 total cells IV.
Receives: Biological: Allogeneic Human Mesenchymal Stem Cells

What is being measured

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

  1. Amount of systemically infused (MSC) DNA relative to recipient DNA at sites of prostate cancer in men with localized adenocarcinoma of the prostate that are scheduled to undergo a prostatectomy

    Allogeneic MSCs will be quantified through tissue BEAMing and the percent of MSCs per total cell number will be calculated.

    Measured: Up to 3 years

Secondary outcomes (12)

  1. Feasibility of infusing MSCs into men with localized prostate cancer who plan to undergo a prostatectomy.

    The percentage of screened subjects that agreed to receive a pre-prostatectomy infusion of MSCs at the pre-specified time point and subsequently undergo a radical prostatectomy.

    Measured: Up to 3 years

  2. Determine the proportion of MSC to recipient DNA in the peripheral blood

    Proportion of MSC to recipient DNA is calculated by number of MSCs over the number of recipient DNA ([number of MSC]/[number of recipient DNA]) in the peripheral blood.

    Measured: Up to 3 years

  3. Determine the proportion of MSC to recipient DNA within the seminal vesicle.

    Proportion of MSC to recipient DNA is calculated by number of MSCs over the number of recipient DNA ([number of MSC]/[number of recipient DNA]) in the seminal vesicle.

    Measured: Up to 3 years

  4. Changes in the Sexual Health Inventory for Men (SHIM) survey post-prostatectomy.

    The SHIM is a measure of sexual function with a score ranging from 1 (severe erectile dysfunction) to 25 (normal function). Participants are required to have a score of >=17 to be eligible for the study.

    Measured: Up to 3 years

  5. Change in urinary function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy

    Change in total urinary function score (possible score range from 5-51) on the EPIC survey.

    Measured: Baseline to Up to 3 years

  6. Change in bowel habits as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy

    Change in total bowel habits score (possible score range from 8-62) on the EPIC survey.

    Measured: Baseline to Up to 3 years

  7. Change in sexual function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy

    Change in total sexual function score (possible score range from 10-61) on the EPIC survey.

    Measured: Baseline to Up to 3 years

  8. Change in hormonal function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy

    Change in total hormonal function score (possible score range from 5-49) on the EPIC survey.

    Measured: Baseline to Up to 3 years

  9. Change in overall satisfaction as assessed by the Expanded Prostate Cancer Index Composite (EPIC) survey post-prostatectomy

    Change in overall satisfaction score (possible score range from 1-5) on the EPIC survey with a higher score reflecting higher overall satisfaction.

    Measured: Baseline to Up to 3 years

  10. Safety as assessed by number of participants experiencing adverse events

    Number of participants experiencing adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.

    Measured: Up to 3 years

  11. Safety as assessed by number of participants experiencing serious adverse events

    Number of participants experiencing serious adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.

    Measured: Up to 3 years

  12. Safety as assessed by number of participants experiencing treatment-related adverse events

    Number of participants experiencing treatment-related adverse events as defined by the revised National Cancer Institute Common Toxicity Criteria (NCI CTC), version 4.0 published 14 June 2010.

    Measured: Up to 3 years

Timeline

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

  1. First posted14 Nov 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionJun 2017
  4. Study completionJun 2017

Why it stopped: Study was Terminated by PI due to low accrual

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01983709
Sponsor's protocol ID
J1348
Other IDs
NA_00083720
Acronym
MSC
Status last verified
Jul 2018
First submitted
28 Oct 2013
Last updated
16 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871. No abstract available.

    PubMed 25974235

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Allogeneic Human Mesenchymal Stem Cells in people with Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 12 inclusion and 15 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 16 Jul 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 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.

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 (reason given: Study was Terminated by PI due to low accrual). 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?

Amount of systemically infused (MSC) DNA relative to recipient DNA at sites of prostate cancer in men with localized adenocarcinoma of the prostate that are scheduled to undergo a prostatectomy (time frame: Up to 3 years). 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 NCT01983709, 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 16 Jul 2018.

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MSC Clinical Trial NCT01983709 | AzTrials