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A theraputic efficacy and safety evaluation of human umbilical cord mesenchymal stem cells combined with neural stem cells therapy for treating amyotrophic lateral sclerosis (ALS)

A theraputic efficacy and safety evaluation of human umbilical cord mesenchymal stem cells combined with neural stem cells therapy for treating amyotrophic lateral sclerosis (ALS)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017734
Enrollment
Unknown
Registered
2018-08-11
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

Case series:hUCMSC+NSC therapy

Sponsors

Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 -70 years old men and women; 2. Meet the diagnostic criteria for Amyotrophic Lateral Sclerosis (ALS); 3. There are no other neurologic related diseases except ALS; 4. fail to respond to conventional therapy; 5. The eligible patients are with no severe non-reversible cardiopulmonary function impairment; No pulmonary and systemic infection; 6. Non tumor patients; 7. The eligible patients are with no history of severe allergy to drugs; 8. Non immunodeficiency patients; 9. Sign informed consent; 10. Good compliance, Family members agreed to cooperate follow up.

Exclusion criteria

Exclusion criteria: 1. With other neurologic related diseases except ALS . 2. ALS patients with severe non-reversible cardiopulmonary, liver, brain function impairment; 3. ALS patients with mental illness or severe neurosis; 4. ALS patients who cannot express the symptoms of subjective discomfort; 5. Participation in other clinical trials in latest 6 months; 6. ALS patients with malignant tumor; 7. Suffering from immunodeficiency disease; 8. Pregnant woman,Breast-feeding women; 9. ALS patients with a history of drug allergy; 10. Any factors that may affect the compliance, safety and test results of this study.

Design outcomes

Primary

MeasureTime frame
ALSFRS-R;Myasthenia and muscular atrophy;Muscle tremor;Pyramidal sign;Bulbar paralysis;Atrophy and fibrillation of lingual muscle;Dysphagia;Dyspnea;Electrophysiological detection;

Secondary

MeasureTime frame
Cognitive dysfunction;Sphincter disorder (Dysuria);MRI examination of the brain and spinal cord;Autoantibody detection;Glutamic acid concentration;FVC;Limb movement score of Carr-Shrphard;Dysarthria score of Frenchay;Balance ability Berg score;Functional independence assessment FM score;

Countries

China

Contacts

Public ContactZhao Zhenlin

Shenzhen Ruipuxun Academy for Stem Cell & Regenerative Medicine

zhaozl2006@163.com+86 13828895409

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026