Acupuncture-induced mobilization of neurogenic stem cells
ISRCTN | ISRCTN71857369 |
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DOI | https://doi.org/10.1186/ISRCTN71857369 |
Secondary identifying numbers | 2009/112 |
- Submission date
- 05/02/2019
- Registration date
- 18/02/2019
- Last edited
- 18/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
The aim of this study is to measure cellular mechanisms before and after acupuncture treatment in patients with traumatic spinal cord injuries. The cellular mechanisms measured are possibly responsible for regeneration of the spinal cord.
Who can participate?
Patients aged 18-60 with traumatic spinal cord injuries
What does the study involve?
Participants undergo 15 acupuncture treatments consisting of the manual stimulation of 11 acupuncture points. Before and after each treatment blood samples are taken. Also, before the first and after the last acupuncture, neurological functions are tested by experienced examiners and classified according to the American Spinal Injury Association. Their quality of life is monitored with a standardized questionnaire.
What are the possible benefits and risks of participating?
Benefits are acupuncture treatments and two additional neurological examinations. Risks include local bruising due to acupuncture needles and taking blood samples. Changes in blood pressure may occur.
Where is the study run from?
Patients were recruited in Bayreuth and Erlangen, blood analyses are performed in Berlin, Ludwigshafen and Mannheim, Germany.
When is the study starting and how long is it expected to run for?
September 2010 to March 2015
Who is funding the study?
The study was funded by the German Medical Association for Acupuncture and the Chinese Scientific Council
Who is the main contact?
1. Dr Sonja Moldenhauer
sonja.moldenhauer@gmx.de
2. Dr Anja Moldenhauer
anja.moldenhauer@uni-saarland.de
Contact information
Scientific
Moorenstr. 5
Düsseldorf
40225
Germany
Phone | +49 211 8119544 |
---|---|
anja.moldenhauer@uni-saarland.de |
Public
Dompfaffstr. 123
Erlangen
91056
Germany
Phone | +49 9131 42711 |
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sonja.moldenhauer@gmx.de |
Study information
Study design | Pilot single-center non-controlled non-randomized study |
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Primary study design | Interventional |
Secondary study design | Non randomised study |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | Acupuncture-induced mobilization of CD133(+) 34(-) neuroprogenitors in patients with spinal cord injuries |
Study acronym | AIMNP |
Study objectives | Manual acupuncture induces an increase of neuroprogenitors in patients with spinal cord injuries leading to a clinical improvement. |
Ethics approval(s) | 2007: Charité - Univeristätsmedizin Berlin EA2/095/2007 2008: Ethics Committee of the Bavarian Medical Chamber Munich, 7/08111 |
Health condition(s) or problem(s) studied | Spinal cord injuries |
Intervention | Four patients were treated 15 times with manual acupuncture twice per week over a period of 2 months. Before and after each acupuncture, differential blood counts, the number of CD133(+)34(-) and CD34(+) cells as well as CD14(+) and CD4(+) cells, brain-derived neurotrophic factor (BDNF) and matrix metalloproteinase (MMP) 9 concentrations were determined. Before and after the treatment period ASIA scores were determined to assess sensor and motor functions and their quality of life was assessed. |
Intervention type | Procedure/Surgery |
Primary outcome measure | Mobilization of CD133(+)34(-) cells) measured by flow cytometry of whole blood before and after each acupuncture treatment (30 times per patient) |
Secondary outcome measures | Before the first (baseline) and after the last acupuncture (15th): 1. Quality of life measured by SF-36 2. Clinical changes measured by ASIA scores |
Overall study start date | 01/09/2010 |
Completion date | 15/03/2015 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 4 |
Key inclusion criteria | Spinal cord injuries for at least 6 months, ASIA score A |
Key exclusion criteria | Need for mechanical ventilation and history of stroke, transient ischemic attack, epilepsy, Parkinson’s disease, multiple sclerosis, bleeding diathesis, cardiovascular diseases, severe diabetes, fever, chronic diarrhea, or severe mental disorders during the preceding 6 months |
Date of first enrolment | 01/10/2011 |
Date of final enrolment | 11/03/2013 |
Locations
Countries of recruitment
- Germany
Study participating centres
Charitéplatz 1
Berlin
10117
Germany
Bremserstr. 79
Ludwigshafen
67063
Germany
Hohe Warte 8
Bayreuth
95445
Germany
Erlangen
91056
Germany
Mannheim
68163
Germany
Sponsor information
Research organisation
Würmtalstraße 54
81375 München
Munich
81375
Germany
Phone | 089 7100511 |
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wissenschaftszentrum@daegfa.de | |
Website | https://www.daegfa.de |
Government
No. 9 Chegongzhuang Ave.
Beijing
100044
China
Phone | 86 10 66093900 |
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wumingyuan@sjtu.edu.cn | |
Website | https://www.csc.edu.cn/ |
Funders
Funder type
Research organisation
No information available
Government organisation / National government
- Alternative name(s)
- CSC
- Location
- China
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | The data on healthy volunteers has already been published. The ex vivo generation of neural cells from acupuncture patients is accepted for publication. The trialists plan to publish the results in the near future. |
IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sonja Moldenhauer (sonja.moldenhauer@gmx.de). |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/06/2010 | Yes | No |