Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency

NCT05345418 | Recruiting Phase 1

• 1 other identifier: ISC.21.08
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

Sexual functional deficiency affects largely the physical conditions, life and sexual quality of the patients. Hypogonadism affects about 4 to 5 million men in the US, and the incidence increases with age. In our recent phase I clinical trial, we have shown that intravenous adipose - derived MSC administration was safe in female and male patients with hormone deficiency. Post-transplantation sexual satisfaction was observed in all patients enrolled in this study. Testosterone levels in males increased significantly after transplantation and were maintained at high levels for up to 6 months before decreasing again at the 12-month follow-up. The aim of this clinical trial was to assess the safety and effectiveness of allogeneic administration of MSCs in middle-aged people with sexual functional deficiency.

Conditions

Sexual Dysfunction Male

Keywords

Sexual Dysfunction Male; reproductive hormones; mesenchymal stem Cell

Outcome Measures

Primary Outcomes (5)

• The safety of allogenic umbilical cord-derived mesenchymal stem cell administration for the treatment of hormone deficiency in male

  To assess safety, the number of AEs or SAEs during stem cell administration up to the 12-month period following treatment will be evaluated

  up to the 12-month period following treatment

• Testosterone levels

  To evaluate the Testosterone levels of the patients with sexual functional deficiency

  up to the 12-month period following treatment

• Changes in sexual life quality using Aging Men Symptom (AMS)

  AMS includes 10 items

  up to the 12-month period following treatment

• Changes in sexual life quality through quantification of International Index of Erectile Function (IIEF)

  IIEF includes 15 items

  up to the 12-month period following treatment

• Changes in sexual life quality through quantification of Sexual Quality of Life Questionnaire (SQoL-M)

  IIEF includes 11 items

  up to the 12-month period following treatment

Study Arms (2)

Umbilical Cord-Derived Mesenchymal Stem Cell, then Placebo (group A)

EXPERIMENTAL

Cohort 1 will receive two single intravenous dose of UC MSCs of 1.5 million cells per kilogram body weight on their Study Month 0, and Study Month 3. \- Each treatment period was separated by a 4 - week washout to allow the effective systemic elimination of the UC MSCs before subsequent treatment initiation

Biological: Umbilical Cord-Derived Mesenchymal Stem Cell for Male Patients with Sexual Deficiency

Placebo, then Umbilical Cord-Derived Mesenchymal Stem Cell (group B)

ACTIVE COMPARATOR

Cohort 2 will receive two single intravenous dose of UC MSCs of 1.5 million cells per kilogram body weight on their Study Month 7, and Study Month 10

Biological: Umbilical Cord-Derived Mesenchymal Stem Cell for Male Patients with Sexual Deficiency

Interventions

Umbilical Cord-Derived Mesenchymal Stem Cell for Male Patients with Sexual Deficiency BIOLOGICAL

Patients will receive two administrations at a dose of 1.5 million cells/kg patient bodyweight via the IV route with a 3-month intervening interval. A validated umbilical cord blood mesenchymal stem cells (UC-MSC) line was selected from the Vinmec Tissue Bank and cultured under xeno-free, serum-free and antibiotic-free conditions as previously described. To prepare UC-MSCs for therapy, aliquots of Passage 3 (P3) UC-MSCs will be thawed and cultured to P5 to get approximately 500 million cells and dispensed to 10 million UC-MSCs/ml/vial for cryopreservation. Upon request from the clinical team, aliquots of P5 UC-MSCs will be thawed in a temperature control water bath or incubator on the infusion day. The UC-MSCs will be washed and suspended in Ringer Lactate.

Placebo, then Umbilical Cord-Derived Mesenchymal Stem Cell (group B); Umbilical Cord-Derived Mesenchymal Stem Cell, then Placebo (group A)

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: males with sexual hormone deficiency
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males with sexual hormone deficiency aged 50 to 70 years
• AMS score ≥ 27
• IIEF \< 14
• SQoL-M ≤ 87
• and Testosterone ≤ 12 nMol/L
• Normal liver function (ALT, AST and Bilirubin are normal according to biological index of Vietnamese people).
• Normal kidney function is usually according to the biological index of Vietnamese people.
• No infection, HIV, HBV, active syphilis.
• Must provide written informed consent.

You may not qualify if:

• The patient had surgery to remove the gonads.
• Patients with a history of cancer, or undergoing cancer treatment, or are positive for cancer screening tests including: PSA, AFP, Pepsinogen I, Pepsinogen II and erythrocyte smear test.
• The patient is taking anti-rejection drugs.
• Patients with malformations, malformations or tumors of the endocrine glands.
• Endocrine impairment due to diabetes (HBA1c \> 7) and other metabolic diseases.
• Patients with active autoimmune disease or positive for antinuclear antibodies.
• Patients with severe heart failure, severe renal failure, severe liver failure, severe respiratory failure, history of cerebral infarction, myocardial infarction, Alzeimer.
• Patients with hypothyroidism.
• The patient has an acute infection.
• Patients with clinically significant coagulopathy or other hematological diseases.
• History of allergy to anesthetics, anesthetics, antibiotics.
• Patients who are using other hormone-improving drugs or supplements (including Sildenafil) in the last 2 weeks or want to continue using these drugs during the study period.
• The patient is a smoker.

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

RECRUITING

Related Publications (3)

• Zhang ZY, Xing XY, Ju GQ, Zhong L, Sun J. Mesenchymal stem cells from human umbilical cord ameliorate testicular dysfunction in a male rat hypogonadism model. Asian J Androl. 2017 Sep-Oct;19(5):543-547. doi: 10.4103/1008-682X.186186.

  PMID: 27586027 BACKGROUND

• Kouchakian MR, Baghban N, Moniri SF, Baghban M, Bakhshalizadeh S, Najafzadeh V, Safaei Z, Izanlou S, Khoradmehr A, Nabipour I, Shirazi R, Tamadon A. The Clinical Trials of Mesenchymal Stromal Cells Therapy. Stem Cells Int. 2021 Nov 3;2021:1634782. doi: 10.1155/2021/1634782. eCollection 2021.

  PMID: 34745268 BACKGROUND

• Kadihasanoglu M, Ozbek E. Mesenchymal stem cell therapy in treatment of erectile dysfunction: Autologous or allogeneic cell sources? Int J Urol. 2016 Apr;23(4):348-9. doi: 10.1111/iju.13058. Epub 2016 Jan 28. No abstract available.

  PMID: 26822742 BACKGROUND

Study Officials

• Tan Sinh Nguyen, Dr

  Vinmec Times City International Hospitalme

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phuong Nguyen, MSC

CONTACT

+84 914740683; v.phuongnh9@vinmec.com

Liem Nguyen, PhD

CONTACT

v.liemnt@vinmec.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 25, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: December 30, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)