Acupuncture-induced mobilization of neurogenic stem cells

ISRCTN	ISRCTN71857369
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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Anja Moldenhauer
Scientific

Moorenstr. 5
Düsseldorf
40225
Germany

Phone	+49 211 8119544
Email	anja.moldenhauer@uni-saarland.de

Dr Sonja Moldenhauer
Public

Dompfaffstr. 123
Erlangen
91056
Germany

Phone	+49 9131 42711
Email	sonja.moldenhauer@gmx.de

Study information

Study design	Pilot single-center non-controlled non-randomized study
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
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

Charite - Universitätsmedizin Berlin

Department of Psychiatry and Psychotherapy
Charitéplatz 1
Berlin
10117
Germany

Klinikum der Stadt Ludwigshafen

Institute for Hemostaseology and Transfusion Medicine
Bremserstr. 79
Ludwigshafen
67063
Germany

Klinikum Hohe Warte

Department of Neurology
Hohe Warte 8
Bayreuth
95445
Germany

Clinic for Acupuncture

Dompfaffstr. 123
Erlangen
91056
Germany

University of Applied Sciences Mannheim

Paul-Wittsack-Straße 10
Mannheim
68163
Germany

Sponsor information

German Medical Acupuncture Association
Research organisation

Würmtalstraße 54
81375 München
Munich
81375
Germany

Phone	089 7100511
Email	wissenschaftszentrum@daegfa.de
Website	https://www.daegfa.de

China Scholarship Council
Government

No. 9 Chegongzhuang Ave.
Beijing
100044
China

Phone	86 10 66093900
Email	wumingyuan@sjtu.edu.cn
Website	https://www.csc.edu.cn/

Funders

Funder type

Research organisation

German Medical Acupuncture Association

No information available

China Scholarship Council
Government organisation / National government

Alternative name(s): CSC
Location: China

Results and Publications

Intention to publish date
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