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Clinical study for neurorestorative effect of olfactory ensheathing cells and olfactory neurons by intranasal delivery for patients with Parkinson Disease

Clinical study for neurorestorative effect of olfactory ensheathing cells and olfactory neurons by intranasal delivery for patients with Parkinson Disease

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026210
Enrollment
Unknown
Registered
2019-09-26
Start date
2017-06-01
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

Parkinson Disease

Interventions

Goup 1:Routine basic treatment + 5 million olfactory ensheathing cells per side through the submucosal approach (0.3ml)
Group 1:Routine basic treatment + 5 million olfactory neurons per side injected through the submucosal approach (0.3ml)
Group 3:Routine basic treatment + 2.5 million olfactory ensheathing cells and 2.5 million olfactory neurons (0.3 ml) per side of the submucosal approach
Group 4:Routine basic treatment + percutaneous submucosal approach to each side of the culture medium (0.3ml)

Sponsors

Tsinghua University Yuquan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for Parkinson's disease; 2. Aged 40 to 80 years old; 3. With full capacity; 4. Being willing and able to participate in the follow-up trials of this study.

Exclusion criteria

Exclusion criteria: 1. H-Y scale classification > 4 grades; 2. Patients With various secondary Parkinson's syndrome and Parkinson's superposition syndrome; 3. Patients with dementia, mental disorders, cognitive disorders, etc. who cannot communicate; 4. Patients with heart, lung, liver or kidney failure, due to severe anemia. Or a disease that has been diagnosed (such as a mental illness), it is difficult to complete a study for up to 1 year; 5. Those who have participated in other clinical trials in the past 3 months; 6. The investigator judged that the adherence was poor and the treatment plan could not be strictly enforced.

Design outcomes

Primary

MeasureTime frame
Classification of Parkinson's disease severity;Parkinson's Disease Rating;Parkinson's disease rating;Cognitive Assessment;Mental State;Barthel index;

Countries

China

Contacts

Public ContactQiao Liyan

Tsinghua University Yuquan Hospital

qiaoliyan2000@aliyun.com+86 13693038870

Outcome results

None listed

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