Penile Intracavernosal Stem Cells Therapy for Erectile Dysfunction

Elaj medical centers

Status and phase: Unknown; Phase 2

Conditions: Erectile Dysfunction

Treatments: Procedure: liposuction for retrieval of own stem cells from fat cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02665520

Elaj stem cells 1

Details and patient eligibility

About

Autologous Fat Derived Stem Cell treatment of ED.

To assess safety and primary efficacy of stem cell infusion in refractory ED.

To investigate the success rate and durability of success of using this new therapy in management of moderate and sever cases of erectile dysfunction.

Enrollment: 30 estimated patients

Sex: Male

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male 40 years old and older suffering from moderate to sever erectile dysfunction -

Exclusion criteria

• Inability to give informed consent or attend follow up
• Severe diabetic neuropathy (to be defined ? Charcot joints, diabetic ulcers?) or other neuropathic disease
• Viral disease from infectivity viewpoint
• Major penile fibrosis or severe Peyronie's disease
• Severe primary large vessel ED (defined as PSV less than 15cm/s after ICI)
• Severe primary venous leakage ED (defined as EDV more than 10cm/s after ICI)
• Prior systemic chemotherapy, or radiotherapy to donor or recipient area
• Not in potentially active sexual relationship
• Age less than 40 or over 70

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

stem cells injection in penis

Active Comparator group

Description:

Treatment Injection of adipose derived cells into penis experimental;randomised

Treatment:

Procedure: liposuction for retrieval of own stem cells from fat cells

controled arm

No Intervention group