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Umbilical cord wrap may help men recover faster after prostate cancer surgery

NCT ID NCT04263025

Symptom relief Sponsor: Hackensack Meridian Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether placing a cryopreserved umbilical cord allograft around nerves during robotic prostatectomy helps men regain erectile function and bladder control sooner. About 100 men with prostate cancer will be randomly assigned to receive either standard surgery or surgery plus the cord wrap. Researchers will track recovery over 12 months using questionnaires.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cryopreserved umbilical cord allograft (CLARIX® CORD 1K)
What this could lead to
If it works, this could help men regain sexual and bladder control faster after prostate cancer surgery.
What could go wrong
This is an early-to-mid-stage trial with only 100 participants, so results may not apply to everyone. The allograft is a processed tissue product, and its long-term benefits or risks are not yet fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

100 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 70 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male aged between 30 and 70 years old 2. Primary diagnosis of organ confined prostate cancer 3. Scheduled to undergo bilateral, nerve-sparing RARP 4. Patient has ICIQ-SF score \<6 5. Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26) 6. Patient is willing to return for all visits as defined in the protocol 7. Patient is willing to follow the instruction of the Investigator 8. Patient has provided written informed consent Exclusion Criteria: 1. Previous history of pelvic radiation 2. Previous history of simple prostatectomy or transurethral prostate surgery 3. Previous history of systemic therapy for prostate cancer 4. Patient has neurogenic bladder 5. Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2 6. History of open pelvic surgery within 5 years except for hernia repair 7. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period. 8. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments 9. Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study 10. Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.