Erectile Dysfunction Treatment Using Stem Cells

COR clinic of Regenerative Medicine

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Erectile Dysfunction

Treatments: Combination Product: UC-MSCs and PRP

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06550752

S2024-cor002

Details and patient eligibility

About

A prospective clinical study to investigate the safety and efficacy of intracavernosal injections of umbilical cord stem cells (UCSCs) combined with platelet-rich plasma (PRP) for erectile dysfunction

Full description

Umbilical cord mesenchymal stem cells (UC-MSCs) combined with platelet-rich plasma (PRP) will be injected into the corpora cavernosa of the penis of male patients with erectile dysfunction. The injection will be done at four points along the shaft on both sides of the penis. Penile Doppler ultrasonography will be performed on all patients before the initiation of the treatment. This assessment will be conducted to establish a baseline measurement of penile blood flow in both left and right sides of the penis. Subsequently, after four months of treatment, penile duplex Doppler ultrasonography will be repeated to compare the penile doppler before and after treatment. Statistical analyses will be performed using IBM SPSS Statistics for Windows, version 26.

Enrollment: 30 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• male patient with erectile dysfunction

Exclusion criteria

• undergo other treatments for erectile dysfunction

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Mixture UC-MSCs and PRP

Experimental group

Description:

A mixture of UCSCs and PRP will be injected into the corpora cavernosa of the penis of each patient. The injection will be done at four points along the shaft on both sides of the penis. The injection procedure will be performed once per month for a total duration of three months. Each patient received a dosage of 10 million cells per injection session.

Treatment:

Combination Product: UC-MSCs and PRP