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Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula

T

Tehran University of Medical Sciences

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Fistula Perianal

Treatments

Other: placenta-MSCs derived exosomes

Study type

Interventional

Funder types

Other

Identifiers

NCT05402748
IRCT20211212053361N1

Details and patient eligibility

About

Study aim:

Safety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula 2.Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of refractory Anal Fistula 3.Fistula changes in MRI studies, 12 weeks after treatment 4.Evaluation of quality of life in perianal fistula patient's questionnaire score before and 12 weeks after treatment

Participants/Inclusion and exclusion criteria:

inclusion Criteria : 1.Age between 18-70 years old 2.Occurrence of complex perianal fistula 3.Informed consent Exclusion Criteria: 1.Active inflammatory bowel disease 2.Synchronous perianal abscess 3.Alcohol,narcotic and stimulant consumption 4.Having active Hepatitis B,C,HIV or TB 5.Peregnancy and lactation 6.Uncontrolled diabetes mellitus 7.Evidence of surgical contraindication 8.Psychological disorders and noncooperative patient

Intervention groups:

Human Placenta Mesenchymal Stem Cells Derived Exosomes injected in fistula tract of patients with complex perianal Fistula in 3 weekly episodes and it's safety and efficacy was evaluated.

Design:

this study includes two separate groups of cases and controls each consisting of 40 participants randomly allocated for the phase 2 of clinical trial.

Settings and conduct:

Patients with complex perianal fistula referred to Imam Khomeini hospital, will be included in the study if they contain inclusion criteria. The fistula was evaluated by clinical examination and MRI and patients fill the quality of life questionnaire. Exosome injections are performed weekly for consecutive three weeks. Patients will reexamined and fill the questionnaire and MRI will done 12 weeks later. Recent findings will compare with the initial data. During this period, patients are examine for complications.

Main outcome variables:

Discharge amount; External orifice re-epithelialization ; Inflammation, discharge and abscess larger than 2 cm in MR imaging; Quality of life questionnaire score, Inflammatory markers such as CRP, IL-6, TNF-a, calprotectin

Enrollment

80 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age between 18-70 years old
  2. Occurrence of complex perianal fistula
  3. Informed consent

Exclusion criteria

  1. Active inflammatory bowel disease
  2. Synchronous perianal abscess
  3. Alcohol,narcotic and stimulant consumption
  4. Having active Hepatitis B,C,HIV or TB
  5. Peregnancy and lactation
  6. Uncontrolled diabetes mellitus
  7. Evidence of surgical contraindication
  8. Psychological disorders and noncooperative patient

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups, including a placebo group

exosome cases
Experimental group
Description:
The patients whose fistula is treated by exosome (40 patients).
Treatment:
Other: placenta-MSCs derived exosomes
Controls
Placebo Comparator group
Description:
The patients whose fistula is treated with conventional treatment plan (40 patients).
Treatment:
Other: placenta-MSCs derived exosomes

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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