Mesenchymal Stemcells for Radiation Induced Xerostomia (MESRIX)
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| ClinicalTrials.gov Identifier: NCT02513238 |
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Recruitment Status :
Completed
First Posted : July 31, 2015
Results First Posted : December 28, 2022
Last Update Posted : December 28, 2022
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Xerostomia |
| Interventions |
Drug: Mesenchymal stem cell Drug: Isotonic NaCl |
| Enrollment | 30 |
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Stemcells Injected Into Submandibularis | Saltwater Injected Into Submandibularis |
|---|---|---|
 Arm/Group Description |
The surgical procedure is done under local anaesthesia using ultrasonic guidance and sterile technique. After receiving the MSC-suspension , the surgeon will identify the submandibular glands and inject the suspension MSCs into the submandibular gland. Calculation of injected number of MSCs pr. participant rests on the following calculation: 2.8 x 10^6 MSC / Cm^3 X volume , where volume is the volume of the submandibular gland, and a gland-volume of app. 7-8cm3 is the norm. Therefore the amount of cells given to each participant will be app. 4.6 x 10^7 MSC in total. Afterwards the participant will be given a band-aid and over the counter analgesics. Mesenchymal stem cell: Stemcells injected into submandibularis |
The surgical procedure is done under local anaesthesia using ultrasonic guidance and sterile technique. After receiving the placebo-suspension , the surgeon will identify the submandibular glands and inject the suspension. Placebo will be 2ml of Isotonic NaCl (0,9mg/ml) and HA 1%. Isotonic NaCl |
| Period Title: Overall Study | ||
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not Completed | 0 | 0 |
| Arm/Group Title | Stemcells Injected Into Submandibularis | Saltwater Injected Into Submandibularis | Total | |
|---|---|---|---|---|
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Arm/Group Description |
The surgical procedure is done under local anaesthesia using ultrasonic guidance and sterile technique. After receiving the MSC-suspension , the surgeon will identify the submandibular glands and inject the suspension MSCs into the submandibular gland. Calculation of injected number of MSCs pr. participant rests on the following calculation: 2.8 x 10^6 MSC / Cm^3 X volume , where volume is the volume of the submandibular gland, and a gland-volume of app. 7-8cm3 is the norm. Therefore the amount of cells given to each participant will be app. 4.6 x 10^7 MSC in total. Afterwards the participant will be given a band-aid and over the counter analgesics. Mesenchymal stem cell: Stemcells injected into submandibularis |
The surgical procedure is done under local anaesthesia using ultrasonic guidance and sterile technique. After receiving the placebo-suspension , the surgeon will identify the submandibular glands and inject the suspension. Placebo will be 2ml of Isotonic NaCl (0,9mg/ml) and HA 1%. Isotonic NaCl |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 15 | 15 | 30 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 15 participants | 15 participants | 30 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
15 100.0%
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15 100.0%
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30 100.0%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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| Number Analyzed | 15 participants | 15 participants | 30 participants | |
|
60
(45 to 65)
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60
(40 to 65)
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60
(40 to 65)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 15 participants | 15 participants | 30 participants | |
| Female |
5 33.3%
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5 33.3%
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10 33.3%
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| Male |
10 66.7%
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10 66.7%
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20 66.7%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 0 participants | 0 participants | 0 participants | |
| 0 | ||||
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[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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| Denmark | Number Analyzed | 15 participants | 15 participants | 30 participants |
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15 100.0%
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15 100.0%
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30 100.0%
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| Name/Title: | Principal Investigator, Mesrix |
| Organization: | Rigshospitalet |
| Phone: | 26276374 |
| EMail: | c.gronhoj@gmail.com |
| Responsible Party: | Christian Grønhøj Larsen, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT02513238 |
| Other Study ID Numbers: |
1406653 |
| First Submitted: | July 2, 2015 |
| First Posted: | July 31, 2015 |
| Results First Submitted: | May 1, 2018 |
| Results First Posted: | December 28, 2022 |
| Last Update Posted: | December 28, 2022 |