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Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury

C

Chinese Academy of Sciences

Status and phase

Unknown
Phase 1

Conditions

Brain Injury

Treatments

Procedure: Stereotactic Hematoma Evacuation
Biological: Injectable Collagen Scaffold with MSCs Transplantation
Biological: MSCs Transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT02767817
CAS-XDA-BI/IGDB

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain injury.

Enrollment

30 estimated patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male or female,35-75 years old.
  2. The surgery time should be > 6 hours after symptom onset.
  3. Glasgow coma score (GCS) was 9-15.
  4. CT diagnosis of intracerebral hemorrhage (25-40 ml), except for patients with signs of craniotomy to remove the hematoma.
  5. Signed informed consent obtained from the patient or patient's legally authorized representative.

Exclusion criteria

  1. Glasgow coma scale of <8.
  2. Patients suffering severe heart failure, severe lung disease, uremia, cirrhosis, end-stage cancer, coagulation disorders, stroke sequela.
  3. Asphyxia, cardiac arrest or successful cardiopulmonary resuscitation before hospitalization.
  4. Lactating or pregnant woman.
  5. Refuse to sign informed content.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 3 patient groups

Stereotactic Hematoma Evacuation
Sham Comparator group
Treatment:
Procedure: Stereotactic Hematoma Evacuation
MSCs Transplantation
Experimental group
Treatment:
Biological: MSCs Transplantation
Injectable Collagen Scaffold with MSCs Transplantation
Experimental group
Treatment:
Biological: Injectable Collagen Scaffold with MSCs Transplantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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