hUC Mesenchymal Stem Cells (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury

Sclnow Biotechnology

Status and phase: Completed; Phase 1

Conditions: Uterus; Injury

Treatments: Biological: human umbilical cord mesenchymal stem cell; Procedure: intrauterine injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03386708

SCLnow-XY-01

Details and patient eligibility

About

The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Healing Poor after Uterus Injury, and exploring the possible mechanisms of umbilical cord mesenchymal stem cell therapy in Healing Poor After Uterus Injury disease

Full description

This is a random, open label, and self-control experiment. 10 patients are selected and sign consent forms, then divided into one group. Doctors collect the basic information of patient (including age,height, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of healing Poor after Uterus Injury (Menstrual conditions, Visual analogue scale, pregnancies).

All patients receive laboratory and image examination as baseline. Then, cell treatment will be given based on the clinical protocol. Doctors have follow-up visit on 3 and 6 month after treatment, and do efficacy evaluation.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female, with BMI 18-24 kg/m^2
• Meet the clinical standard of Healing Poor After Uterus Injury
• Non smoker
• Do not accept stem cells treatment in 6 months
• Participants or their family members sign the consent form of this study

Exclusion criteria

• Pregnant or breast feeding women
• Age <18 or >40
• Refuse to sign the consent form
• Patients with underlying risk of medical disease history: history of diabetes, serious cardiovascular disease, severe infection, alimentary tract hemorrhage, etc.
• Serum with HIV, syphilis antibody positive
• Severe mental disease, cognitive disorder patients
• Other severe system or organ organic disease
• Participate other clinical experiments in 3 months
• Ovarian and pituitary dysfunction diseases
• With some other conditions that doctor propose not to participate

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

hUC-MSC intrauterine injection group

Experimental group

Description:

Human umbilical cord mesenchymal stem cells (hUC-MSC) (SCLnow 19#)

Treatment:

Procedure: intrauterine injection

Biological: human umbilical cord mesenchymal stem cell