Clinical Trials List
2023-12-01 - 2026-12-31
Phase I
Not yet recruiting2
ICD-10N52.01
Erectile dysfunction due to arterial insufficiency
ICD-10N52.02
Corporo-venous occlusive erectile dysfunction
ICD-10N52.03
Combined arterial insufficiency and corporo-venous occlusive erectile dysfunction
ICD-10N52.1
Erectile dysfunction due to diseases classified elsewhere
ICD-10N52.2
Drug-induced erectile dysfunction
ICD-10N52.31
Erectile dysfunction following radical prostatectomy
ICD-10N52.32
Erectile dysfunction following radical cystectomy
ICD-10N52.33
Erectile dysfunction following urethral surgery
ICD-10N52.34
Erectile dysfunction following simple prostatectomy
ICD-10N52.39
Other post-surgical erectile dysfunction
ICD-10N52.8
Other male erectile dysfunction
ICD-10N52.9
Male erectile dysfunction, unspecified
ICD-9607.84
Impotence of organic origin
An Open-Label, Non-Randomized, Dose-Escalation Phase I Study to Evaluate the Safety of UA002 (Allogeneic Amniotic Fluid Stem Cells) in Subjects with Diabetes Mellitus (DM)- or Radical Prostatectomy (RP)-Associated Erectile Dysfunction (ED)
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Trial Applicant
A2 HEALTHCARE TAIWAN CORPORATION
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Sponsor
U-Neuron Biomedical Inc
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Trial scale
Taiwan Multiple Center
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Update
2025/10/31
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
maximum tolerated dose (MTD) evaluation, and change from
baseline to post-treatment visits in vital signs, 12-lead
electrocardiogram (EKG), and laboratory parameters, prostate
specific antigen (PSA) level (for the RP subjects only), panel
reactive antibody (PRA) level, and the number of subjects
abnormal finding of physical examination and chest X-ray
2. Percentage of subjects with adverse events (AEs), AEs of special
interest (AESIs), and serious adverse events (SAEs) up to 52
weeks
3. Percentage of subjects with immediate AEs
Inclution Criteria
1. Male aged ≥ 18 and ≤ 75 years old
2. For the subject with diabetes mellitus (DM):
a. Has been ever diagnosed with type 1 or type 2 DM and
ever with HbA1c ≥ 6.5% within 3 years prior to the
screening visit
b. Has received and is willing to continue to receive
treatments for DM
c. HbA1c ≤ 10% at the screening visit
d. With EF domain of IIEF score between 11~ 22 at the
screening visit
e. Has never received radical prostatectomy (RP)
f. ED history < 3 years
g. Diagnosed with ED at least 12 weeks prior to the
screening visit
3. For the subject with radical prostatectomy (RP):
a. Prior to RP, the subject had
- Normal erectile function, mild, or mild to moderate ED
(judged by the investigator retrospectively at the
screening visit)
- With localized prostate cancer: prostate specific antigen
(PSA) < 20 ng/mL, pathological Gleason score grade 1
(Gleason score sum ≤ 6 (3+3)) or 2 (Gleason score sum
7 (3+4)), pathological stage ≤ T2 (N0, M0)
b. Received RP within 12 to 104 weeks prior to the screening
visit
c. With PSA ≤ 0.2 ng/mL and without additional radiotherapy
or hormone therapy after RP
d. With EF domain of IIEF score between 6~16 at the
screening visit
Exclusion Criteria
from study participation.
1. Body mass index (BMI) ≥ 30 kg/m2 at the screening visit
2. With systemic autoimmune disease (except type I DM) or primary
hyperlipidemia at the screening visit (for the DM subject only)
3. With systemic autoimmune disease at the screening visit (for the
RP subject only)
4. With any malignant tumor or benign tumor at the screening visit
5. Has received cytotoxic agent, chemotherapy, or radiotherapy
within 4 weeks prior to the screening visit till Day 1
6. ED due to structural abnormality of the penis such as Peyronie's
disease or judged by the investigator
7. Has ever received any surgery at the penile area (except
circumcision)
8. Use of antidepressants within 4 weeks prior to the screening visit
till Day 1
9. Any drug-induced or psychogenic erectile dysfunction within 4
weeks prior to the screening visit
10. History of Coronary Artery Bypass Graft (CABG) surgery within
the last 24 weeks prior to the screening visit till Day 1
The Estimated Number of Participants
-
Taiwan
40 participants
-
Global
0 participants
